SYNVISC ONE
Report
- Report Number
- 2246315-2018-00106
- Event Type
- Death
- Date Received
- January 24, 2018
- Date of Event
- December 17, 2017
- Report Date
- January 7, 2019
- Manufacturer
- GENZYME BIOSURGERY (RIDGEFIELD)
- Product Code
- MOZ
- PMA / PMN Number
- P940015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 02-JAN-2018 FROM CONSUMER (PATIENT'S SON). THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND ON THE SAME DAY HAD PAIN/ HURT ALL DAY & NIGHT; AFTER UNKNOWN LATENCY HAD MOBILITY ISSUES, KNEE DRAINED, WAS WEAK, HOT, COLD SHAKING, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE/ BALANCE ISSUES, FELT SHORT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS/ EASY UPSET SERIOUS PERSONAL CHANGE, DEPRESSED MOOD, FEVER, CHILLS, FATIGUE, HAD BREATHING ISSUES, COORDINATION ISSUES AND TIGHTNESS BEHIND KNEE. THIS IS THE LEFT KNEE; AFTER 44 DAYS HAD SHOT HIMSELF TO DEATH. ALSO DEVICE MALFUNCTION WAS IDENTIFIED FOR THE REPORTED LOT NUMBER. NO RELEVANT CONCOMITANT MEDICATIONS, MEDICAL HISTORY AND CONCURRENT CONDITIONS WERE REPORTED. PATIENT HAD NOT HAD SYNVISC-ONE IN THE PAST OR ANOTHER KNEE INJECTION. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC ONE INJECTION, ONE INJECTION ONCE (LOT NUMBER: 7RSL021; INDICATION AND EXPIRATION DATE: NOT REPORTED). ON THE SAME DAY AFTER RECEIVING SYNVISC ONE INJECTION, IT HURT ALL DAY AND NIGHT CALLED DOCTOR. PATIENT STARTED TO EXPERIENCE THE SYMPTOMS OF PAIN THE SAME DAY AS THE INJECTION AND THE FOLLOWING WEEKEND IT BECAME MUCH WORSE. PATIENT WAS TOLD TO USE ICE AND TYLENOL, HAD TO USE A CANE, TOLD TO GET STEROID SHOT, BUT PATIENT WAS IN SO MUCH PAIN COULD NOT BEAR THE THOUGHT OF GETTING ANOTHER SHOT. THE FOLLOWING TUESDAY AFTER THE SHOT PATIENT STILL COULD NOT DO ANYTHING, THEN WED THE DOCTOR WAS ONLY WORKING HALF DAY AND NURSE TOLD HIM IT WAS A BAD BATCH. ON (B)(6) 2017, PATIENT WAS IN MUCH PAIN WENT TO DOCTOR HAD KNEE DRAINED (ONSET DATE: (B)(6) 2017; LATENCY UNKNOWN) AND CORTISONE AND A SCAN OF HIS KNEE. PATIENT SON DESCRIBED THE KNEE AS LOOKING BRUTAL LOOKING AND HIS FATHER HAVING A FEVER AND CHILLS. IT WAS STATED THAT THE ICE AND TYLENOL THAT WAS RECOMMENDED BY HIS DOCTOR DID NOTHING. PATIENT HAD TO USE A CANE TO WALK. THE KNEE THAT WAS DRAINED HAD A LOT OF FLUID COME OUT OF IT. ON (B)(6) 2017, PATIENT WENT BACK TO DOCTOR AS WAS IN STILL IN PAIN, WEAK, HOT, COLD SHAKING THEN A MONTH OUT FROM THE SHOT SYNVISC-ONE, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE AND FELT SHORT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG , TIGHTNESS BEHIND KNEE, THIS WAS THE LEFT KNEE, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS, DEPRESSED MOOD, EASY UPSET SERIOUS PERSONAL CHANGE (ONSET DATE: (B)(6) 2017, LATENCY UNKNOWN). IT WAS REPORTED THAT AFTER INJECTION PATIENT HAD MORE OF A DEBILITATING AND WAS IN VERY GOOD HEALTH UNTIL SHOT. IT WAS STATED THAT PATIENT WENT TO PHYSICAL THERAPY AFTER (B)(6) 2017 AND AFTER THAT POINT THINGS HAD STARTED TO TURN FOR THE WORSE. PATIENT WAS SUPPOSED TO SEE A SURGEON BEFORE HE HAD SHOT HIMSELF. IT WAS STATED OVERALL PATIENT WAS AN OUTGOING PERSON AND HIS DEPRESSED MOOD CHANGE WAS BEYOND ABNORMAL FOR HIM. IT WAS STATED THAT THERE WAS A POINT THAT HE NEEDED HELP TO GET OFF THE FLOOR BECAUSE OF HIS MOBILITY ISSUES. IT WAS REPORTED THAT PATIENT DOCUMENTED IN A NOTE THAT HE WAS HAVING FATIGUE, BREATHING ISSUES, CHEST PRESSURE, COORDINATION AND BALANCE ISSUES, FEELING DEPRESSED AND MOOD SWINGS WITH PERSONALITY CHANGES. PATIENT SON DESCRIBES ALL OF THIS AS BEYOND UNUSUAL FOR HIM. PATIENT SON SAID HE HAD ANXIETY AND HE WAS EASILY UPSET. ON (B)(6) 2017 NIGHT, 44 DAYS AFTER RECEIVING SYNVISC ONE INJECTION, IT WAS STATED THAT PATIENT SHOT HIMSELF TO DEATH. CORRECTIVE TREATMENT: CORTISONE, ICE & PARACETAMOL (TYLENOL), STEROID SHOT FOR PAIN/ HURT ALL DAY & NIGHT; CORTISONE FOR KNEE DRAINED; CANE FOR MOBILITY ISSUES; NOT REPORTED FOR REST EVENTS OUTCOME: UNKNOWN FOR ALL EVENTS AN INVESTIGATION WAS INITIATED AS A RESULT OF AN UNEXPECTED INCREASE IN THE NUMBER OF LABELLED ADVERSE EVENTS RECEIVED FROM THE US MARKET FOR SYNVISC ONE, LOT 7RSL021. THE PRODUCT MET ALL RELEASE TESTING AT TIME OF MANUFACTURE IN JUNE 2017. RETAIN SAMPLES WERE RETESTED DUE TO THE UNEXPECTED INCREASE IN ADVERSE EVENTS. HIGHER THAN EXPECTED ENDOTOXIN RESULTS WERE OBTAINED. IN ADDITION, THE PRESENCE OF MICROBIAL CONTAMINATION WAS ALSO CONFIRMED. THE CAUSE OF THESE EVENTS WAS UNDER INVESTIGATION. ONCE THIS INVESTIGATION WAS COMPLETED, CORRECTIVE AND PREVENTIVE ACTIONS WOULD BE IMPLEMENTED. SERIOUSNESS CRITERION: DISABILITY FOR MOBILITY ISSUES; REQUIRED INTERVENTION FOR DEVICE MALFUNCTION, KNEE DRAINED AND PAIN/ HURT ALL DAY & NIGHT PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 08-JAN-2018: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED SYNVISC ONE INJECTION FROM THE RECALLED LOT AND LATER PATIENT SHOOT HIMSELF TO DEATH AND HAS MOBILITY ISSUES. BASED UPON THE INFORMATION AVAILABLE, PHARMACOLOGICAL PLAUSIBILITY CANNOT BE ESTABLISHED BETWEEN THE DEATH AND SUSPECT PRODUCT. HOWEVER, MOBILITY ISSUES CAN OCCUR DUE TO KNEE PROBLEM PATIENT WAS FACING DUE TO SYNVISC ONE. ALSO, IT IS HIGHLY UNLIKELY THAT SUSPECTED PRODUCT PLAYED ANY ROLE IN COMPLETED SUICIDE. FURTHERMORE, THE CONCERNED LOT NUMBER HAS BEEN IDENTIFIED TO HAVE MALFUNCTION BY THE COMPANY. HOWEVER, FURTHER INFORMATION REGARDING PATIENT'S CURRENT CLINICAL PRESENTATION, PSYCHIATRIC HISTORY, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS WOULD AID IN THE COMPLETE MEDICAL ASSESSMENT OF THE CASE.
SHOOT HIMSELF TO DEATH [COMPLETED SUICIDE]. MOBILITY ISSUES/ COULDN'T WALK FURTHER THAN THE BATHROOM /EVEN GETTING TO LIVING ROOM. COUCH WAS A SERIOUS STRUGGLE [MOVEMENT DISORDER]. DEVICE MALFUNCTION [DEVICE MALFUNCTION]. KNEE DRAINED/ 15 CC OF FLUID ASPIRATED [KNEE EFFUSION]. PAIN/ HURT ALL DAY & NIGHT [KNEE PAIN] ([CONDITION WORSENED]). WEAK [WEAKNESS] . HOT [FEELING HOT]. COLD SHAKING [FEELING COLD] . COLD SHAKING [SHAKING] . INSIDE OF MOUTH FELT STICKY [DRY MOUTH] . RACING HEART [HEART RACING] . CHEST PRESSURE [CHEST PRESSURE]. LOSS OF BALANCE/ BALANCE ISSUES [BALANCE IMPAIRED NOS]. FELT SHORT TERM MEMORY NOT THE SAME [MEMORY DISTURBANCE] . INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG [BURNING SENSATION] . VISION CHANGES [VISUAL DISTURBANCE] . BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION [BLURRY VISION]. MOOD SWINGS/ EASY UPSET SERIOUS PERSONAL CHANGE/EASILY AGITATED/ CHANGING ALTOGETHER [MOOD SWINGS]. DEPRESSED MOOD [DEPRESSED MOOD]. FEVER [FEVER] . CHILLS [CHILLS]. FATIGUE/DEBILITATING FATIGUE [FATIGUE]. BREATHING ISSUES/ PERIODS OF BREATHING DIFFICULTIES [RESPIRATORY DISORDER]. COORDINATION ISSUES [COORDINATION DISTURBANCE]. TIGHTNESS BEHIND KNEE, THIS IS THE LEFT KNEE [JOINT TIGHTNESS]. BAKER'S CYST/ KNOT IN THE BACK OF KNEE [BAKER'S CYST]. SWELLING IN CALF [CALF SWELLING] . PAIN IN CALF [PAIN IN CALF]. TIGHTNESS IN CALF [CALF DISCOMFORT]. SWELLING IN THE KNEE [KNEE SWELLING] ([CONDITION WORSENED]). KNEE BOTHERED HIM [DISCOMFORT IN JOINTS]. PAIN INTO THE CALF AND UPTO HIS THIGH [RADIATING PAIN]. CREPITANCE [JOINT CREPITATION]. FLAIR REACTION TO SYNVISC ONE/ HORRIBLE ADVERSE REACTION [ALLERGIC REACTION]. SYNOVITIS [SYNOVITIS]. METHYLOBACTERIUM THIOCYANATUM [METHYLOBACTERIUM INFECTION]. DEMENTIA [DEMENTIA] . MUSCLE STIFFNESS [MUSCLE STIFFNESS]. AT NO TIME DID IT GIVE HIM RELIEF [DEVICE INEFFECTIVE]. CASE NARRATIVE: BASED ON INFORMATION RECEIVED ON (B)(6) 2018, CASE BECAME MEDICALLY CONFIRMED. INITIAL INFORMATION RECEIVED ON (B)(6) 2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A CONSUMER/NON-HCP. THIS CASE INVOLVES A (B)(6) YEARS OLD MALE PATIENT WHO EXPERIENCED SHOOT HIMSELF TO DEATH, MOBILITY ISSUES/ COULDN'T WALK FURTHER THAN THE BATHROOM /EVEN GETTING TO LIVING ROOM COUCH WAS A SERIOUS STRUGGLE, DEVICE MALFUNCTION, KNEE DRAINED/ 15 CC OF FLUID ASPIRATED, PAIN/ HURT ALL DAY & NIGHT, WEAK, HOT, COLD SHAKING, COLD SHAKING, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE/ BALANCE ISSUES, FELT SHORT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS/ EASY UPSET SERIOUS PERSONAL CHANGE/EASILY AGITATED/ CHANGING ALTOGETHER, DEPRESSED MOOD, FEVER, CHILLS, FATIGUE/DEBILITATING FATIGUE, BREATHING ISSUES/ PERIODS OF BREATHING DIFFICULTIES, COORDINATION ISSUES, TIGHTNESS BEHIND KNEE , THIS IS THE LEFT KNEE, BAKER'S CYST/ KNOT IN THE BACK OF KNEE, SWELLING IN CALF, PAIN IN CALF, TIGHTNESS IN CALF, SWELLING IN THE KNEE, KNEE BOTHERED HIM, PAIN INTO THE CALF AND UPTO HIS THIGH, CREPITANCE, FLAIR REACTION TO SYNVISC ONE/ HORRIBLE ADVERSE REACTION, SYNOVITIS, METHYLOBACTERIUM THIOCYANATUM, DEMENTIA, MUSCLE STIFFNESS AND AT NO TIME DID IT GIVE HIM RELIEF, WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ARTHROSCOPY IN 2003, TENOPLASTY IN 2005, CATARACT IN 2011, NEPHROLITHIASIS IN 2013, CATARACT IN 2013, SHOULDER ARTHROSCOPY/ RIGHT ROTATOR & TEAR IN 2013, ATRIAL FLUTTER IN 2013, ECHOCARDIOGRAM IN 2014, THERMAL ABLATION IN 2016, COLONOSCOPY ON (B)(6) 2017, SYNOVIAL CYST, PAIN IN EXTREMITY, HYPERTENSION, HYPERLIPIDAEMIA AND TOBACCO USER. THE PATIENT'S PAST MEDICAL TREATMENT INCLUDED FLOMAX [TAMSULOSIN HYDROCHLORIDE] IN (B)(6) 2017 WITH TO EMPTY BLADDER AND LOSARTAN POTASSIUM IN (B)(6) 2017 WITH BLOOD PRESSURE. THE PATIENT'S PAST VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2017, THE PATIENT WAS ADMINISTERED SYNVISC ONE (HYLAN G-F 20, SODIUM HYALURONATE) , INTRA-ARTICULAR INJECTION OF UNKNOWN DOSAGE (LOT - 7RSL021) FOR LEFT KNEE OSTEOARTHRITIS. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA- ARTICULAR SYNVISC ONE INJECTION, ONE INJECTION ONCE (LOT NUMBER: 7RSL021; INDICATION: LEFT KNEE OSTEOARTHRITIS AND EXPIRATION DATE: NOT REPORTED). ON THE SAME DAY AFTER RECEIVING SYNVISC ONE INJECTION, IT HURT ALL DAY AND NIGHT CALLED DOCTOR. PATIENT STARTED TO EXPERIENCE THE SYMPTOMS OF PAIN THE SAME DAY AS THE INJECTION AND THE FOLLOWING WEEKEND IT BECAME MUCH WORSE. IMMEDIATELY HIS BODY REACTED, HIS KNEES WELLED AND WAS IN PAIN, HEC COULDN'T WALK FURTHER THAN THE BATHROOM FROM THE BED, EVEN GETTING TO COUCH WAS A SERIOUS ISSUE THEN PATIENT WAS TOLD TO USE ICE AND TYLENOL, HAD TO USE A CANE , TOLD TO GET STEROID SHOT, BUT PATIENT WAS IN SO MUCH PAIN COULD NOT BEAR THE THOUGHT OF GETTING ANOTHER SHOT. THE FOLLOWING TUESDAY AFTER THE SHOT, PATIENT STILL COULD NOT DO ANYTHING, THEN WED THE DOCTOR WAS ONLY WORKING HALF DAY AND NURSE TOLD HIM IT WAS A BAD BATCH. ON (B)(6) 2017, PATIENT WAS IN MUCH PAIN WENT TO DOCTOR HAD KNEE DRAINED (ONSET DATE: (B)(6) 2017; LATENCY UNKNOWN) AND CORTISONE AND A SCAN OF HIS KNEE. PATIENT SON DESCRIBED THE KNEE AS LOOKING BRUTAL LOOKING AND HIS FATHER HAVING A FEVER AND CHILLS. IT WAS STATED THAT THE ICE AND TYLENOL THAT WAS RECOMMENDED BY HIS DOCTOR DID NOTHING. PATIENT HAD TO USE A CANE TO WALK. PATIENT'S KNEE BOTHERED HIM THROUGHOUT THE WEEK , PATIENT HAD DIFFICULTY WALKING, HAD PAIN AND KNOT IN THE BACK OF KNEE, REPORTED OF CALF GETTING TIGHT, PAINFUL AND SWOLLEN. THE KNEE THAT WAS DRAINED HAD A LOT OF FLUID COME OUT OF IT. ALSO, LEFT POPLITEAL FOSSA BAKER'S CYST WAS DIAGNOSED IN THE PATIENT. AFTER STERILE PREP WITH BETADINE, 45 CC OF CLEAR SYNOVIAL FLUID WAS ASPIRATED FROM LEFT KNEE WITHOUT DIFFICULTY. THEN 8 CC OF MARCAINE AND 2CC/8,G DEXAMETHASONE WAS INJECTED INTRA-ARTICULARLY TO THE LEFT KNEE. ON (B)(6) 2017, PATIENT WENT BACK TO DOCTOR AS WAS IN STILL IN PAIN, WEEK, HOT, COLD SHAKING THEN A MONTH OUT FROM THE SHOT SYNVISC-ONE, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE AND FELT SHORT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG , TIGHTNESS BEHIND KNEE , THIS WAS THE LEFT KNEE, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS, DEPRESSED MOOD, EASY UPSET SERIOUS PERSONAL CHANGE (ONSET DATE: (B)(6) 2017, LATENCY UNKNOWN). PATIENT'S SON REPORTED THAT HIS FATHER EXPERIENCED FEVERS, MUSCLE STIFFNESS AND ANXIETY. HE WAS EASILY AGITATED, LACK OF MOBILITY WAS FRUSTRATING. AT NO TIME DID THE INJECTION GIVE HIM ANY RELIEF. IT WAS REPORTED THAT AFTER INJECTION PATIENT HAD MORE OF A DEBILITATING AND WAS IN VERY GOOD HEALTH UNTIL SHOT. IT WAS REPORTED THAT PATIENT HAD A FLAIR REACTION TO SYNVISC ONE. ON AN UNKNOWN DATE, PATIENT REPORTED OF A REACTION WITH SYNOVITIS. COMPANY REVEALED THAT THERE WAS METHYLOBACTERIUM THIOCYANATUM INFECTION IN THE CONTAMINATED LOT NUMBER OF SYNVISC ONE. PATIENT'S SON REPORTED OF PATIENT HAVING DEMENTIA POST SNVISC ONE INJECTION. IT WAS STATED THAT PATIENT WENT TO PHYSICAL THERAPY AFTER (B)(6) 2017 AND AFTER THAT POINT THINGS HAD STARTED TO TURN FOR THE WORSE. PATIENT WAS SUPPOSED TO SEE A SURGEON BEFORE HE HAD SHOT HIMSELF. IT WAS STATED OVERALL PATIENT WAS AN OUTGOING PERSON AND HIS DEPRESSED MOOD CHANGE WAS BEYOND ABNORMAL FOR HIM. IT WAS STATED THAT THERE WAS A POINT THAT HE NEEDED HELP TO GET OFF THE FLOOR BECAUSE OF HIS MOBILITY ISSUES. IT WAS REPORTED THAT PATIENT DOCUMENTED IN A NOTE THAT HE WAS HAVING FATIGUE, BREATHING ISSUES, CHEST PRESSURE, COORDINATION AND BALANCE ISSUES, FEELING DEPRESSED AND MOOD SWINGS WITH PERSONALITY CHANGES. PATIENT SON DESCRIBES ALL OF THIS AS BEYOND UNUSUAL FOR HIM. PATIENT SON SAID HE HAD ANXIETY AND HE WAS EASILY UPSET. ON (B)(6) 2017 NIGHT, 44 DAYS AFTER RECEIVING SYNVISC ONE INJECTION, IT WAS STATED THAT PATIENT SHOOT HIMSELF TO DEATH. ON CORRECTIVE TREATMENT: CORTISONE, ICE & PARACETAMOL (TYLENOL), STEROID SHOT FOR PAIN/ HURT ALL DAY & NIGHT; CORTISONE, MARCAINE AND DEXAMETHASONE FOR KNEE DRAINED; CANE FOR MOBILITY ISSUES; NOT REPORTED FOR REST EVENTS. OUTCOME: UNKNOWN FOR ALL EVENTS. REPORTER CAUSALITY: RELATED FOR ALL EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4). AN INVESTIGATION WAS INITIATED AS A RESULT OF AN UNEXPECTED INCREASE IN THE NUMBER OF LABELLED ADVERSE EVENTS RECEIVED FROM THE US MARKET FOR SYNVISC ONE, LOT 7RSL021. THE PRODUCT MET ALL RELEASE TESTING AT TIME OF MANUFACTURE IN JUNE 2017. RETAIN SAMPLES WERE RETESTED DUE TO THE UNEXPECTED INCREASE IN ADVERSE EVENTS. HIGHER THAN EXPECTED ENDOTOXIN RESULTS WERE OBTAINED. IN ADDITION, THE PRESENCE OF MICROBIAL CONTAMINATION WAS ALSO CONFIRMED. THE CAUSE OF THESE EVENTS WAS UNDER INVESTIGATION. ONCE THIS INVESTIGATION WAS COMPLETED, CORRECTIVE AND PREVENTIVE ACTIONS WOULD BE IMPLEMENTED. SERIOUSNESS CRITERION: DISABILITY FOR MOBILITY ISSUES; REQUIRED INTERVENTION FOR DEVICE MALFUNCTION, KNEE DRAINED AND PAIN/ HURT ALL DAY & NIGHT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM THE HEALTHCARE PROFESSIONAL. MEDICAL HISTORY ADDED. TREATMENT DRUGS ADDED AND NEW EVENTS OF DEMENTIA, CALF PAIN , SWELLING AND TIGHTNESS,BAKER'S CYST, HYPERSENSITIVITY REACTION, METHYLOBACTERIUM THIOCYANATUM INFECTION WERE ADDED WITH DETAILS. CLINICAL COURSE UPDATED AND TEXT AMENDED ACCORDINGLY.
SHOOT HIMSELF TO DEATH [COMPLETED SUICIDE]; MOBILITY ISSUES/ COULDN'T WALK FURTHER THAN THE BATHROOM /EVEN GETTING TO LIVING ROOM COUCH WAS A SERIOUS STRUGGLE [MOVEMENT DISORDER] ; DEVICE MALFUNCTION [DEVICE MALFUNCTION] ; KNEE DRAINED/ 15 CC OF FLUID ASPIRATED [KNEE EFFUSION] ; PAIN/ HURT ALL DAY & NIGHT [KNEE PAIN] ([CONDITION WORSENED]); WEAK [WEAKNESS] ; HOT [FEELING HOT] ; COLD SHAKING [FEELING COLD] ; COLD SHAKING [SHAKING] ; INSIDE OF MOUTH FELT STICKY [DRY MOUTH] ; RACING HEART [HEART RACING] ; CHEST PRESSURE [CHEST PRESSURE] ; LOSS OF BALANCE/ BALANCE ISSUES [BALANCE IMPAIRED NOS] ; FELT SHOT TERM MEMORY NOT THE SAME [MEMORY DISTURBANCE] ; INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG [BURNING SENSATION] ; VISION CHANGES [VISUAL DISTURBANCE] ; BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION [BLURRY VISION] ; MOOD SWINGS/ EASY UPSET SERIOUS PERSONAL CHANGE/EASILY AGITATED/ CHANGING ALTOGETHER [MOOD SWINGS] ; DEPRESSED MOOD [DEPRESSED MOOD] ; FEVER [FEVER] ; CHILLS [CHILLS] ; FATIGUE/DEBILITATING FATIGUE [FATIGUE] ; BREATHING ISSUES/ PERIODS OF BREATHING DIFFICULTIES [RESPIRATORY DISORDER] ; COORDINATION ISSUES [COORDINATION DISTURBANCE] ; TIGHTNESS BEHIND KNEE , THIS IS THE LEFT KNEE [JOINT TIGHTNESS] ; BAKER'S CYST/ KNOT IN THE BACK OF KNEE [BAKER'S CYST] ; SWELLING IN CALF [CALF SWELLING] ; PAIN IN CALF [PAIN IN CALF] ; TIGHTNESS IN CALF [CALF DISCOMFORT] ; SWELLING IN THE KNEE [KNEE SWELLING] ([CONDITION WORSENED]); KNEE BOTHERED HIM [DISCOMFORT IN JOINTS] ; PAIN INTO THE CALF AND UPTO HIS THIGH [RADIATING PAIN] ; CREPITANCE [JOINT CREPITATION] ; FLAIR REACTION TO SYNVISC ONE/ HORRIBLE ADVERSE REACTION [ALLERGIC REACTION] ; SYNOVITIS [SYNOVITIS] ; METHYLOBACTERIUM THIOCYANATUM [METHYLOBACTERIUM INFECTION] ; DEMENTIA [DEMENTIA] ; MUSCLE STIFFNESS [MUSCLE STIFFNESS] ; AT NO TIME DID IT GIVE HIM RELIEF [DEVICE INEFFECTIVE] . CASE NARRATIVE: THE CASE IS CROSS REFERENCED TO (B)(4) (DUPLICATE). BASED ON INFORMATION RECEIVED ON (B)(6) 2018, CASE BECAME MEDICALLY CONFIRMED. INITIAL INFORMATION RECEIVED ON (B)(6) 2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A CONSUMER/NON-HCP. THIS CASE INVOLVES A (B)(6) MALE PATIENT WHO EXPERIENCED SHOOT HIMSELF TO DEATH, MOBILITY ISSUES/ COULDN'T WALK FURTHER THAN THE BATHROOM /EVEN GETTING TO LIVING ROOM COUCH WAS A SERIOUS STRUGGLE, DEVICE MALFUNCTION, KNEE DRAINED/ 15 CC OF FLUID ASPIRATED, PAIN/ HURT ALL DAY & NIGHT, WEAK, HOT, COLD SHAKING, COLD SHAKING, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE/ BALANCE ISSUES, FELT SHOT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS/ EASY UPSET SERIOUS PERSONAL CHANGE/EASILY AGITATED/ CHANGING ALTOGETHER, DEPRESSED MOOD, FEVER, CHILLS, FATIGUE/DEBILITATING FATIGUE, BREATHING ISSUES/ PERIODS OF BREATHING DIFFICULTIES, COORDINATION ISSUES, TIGHTNESS BEHIND KNEE , THIS IS THE LEFT KNEE, BAKER'S CYST/ KNOT IN THE BACK OF KNEE, SWELLING IN CALF, PAIN IN CALF, TIGHTNESS IN CALF, SWELLING IN THE KNEE, KNEE BOTHERED HIM, PAIN INTO THE CALF AND UPTO HIS THIGH, CREPITANCE, FLAIR REACTION TO SYNVISC ONE/ HORRIBLE ADVERSE REACTION, SYNOVITIS, METHYLOBACTERIUM THIOCYANATUM, DEMENTIA, MUSCLE STIFFNESS AND AT NO TIME DID IT GIVE HIM RELIEF, WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ARTHROSCOPY IN 2003, TENOPLASTY IN 2005, CATARACT IN 2011, NEPHROLITHIASIS IN 2013, CATARACT IN 2013, SHOULDER ARTHROSCOPY/ RIGHT ROTATER & TEAR IN 2013, ATRIAL FLUTTER IN 2013, ECHOCARDIOGRAM IN 2014, THERMAL ABLATION IN 2016, COLONOSCOPY ON (B)(6) 2017, SYNOVIAL CYST, PAIN IN EXTREMITY, HYPERTENSION, HYPERLIPIDAEMIA AND TOBACCO USER. THE PATIENT'S PAST MEDICAL TREATMENT INCLUDED FLOMAX [TAMSULOSIN HYDROCHLORIDE] IN (B)(6) 2017 WITH TO EMPTY BLADDER AND LOSARTAN POTASSIUM IN (B)(6) 2017 WITH BLOOD PRESSURE. THE PATIENT'S PAST VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2017, THE PATIENT WAS ADMINISTERED SYNVISC ONE (HYLAN G-F 20, SODIUM HYALURONATE) , INTRA-ARTICULAR INJECTION OF UNKNOWN DOSAGE (LOT - 7RSL021) FOR LEFT KNEE OSTEOARTHRITIS. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA- ARTICULAR SYNVISC ONE INJECTION, ONE INJECTION ONCE (LOT NUMBER: 7RSL021; INDICATION: LEFT KNEE OSTEOARTHRITIS AND EXPIRATION DATE: NOT REPORTED). ON THE SAME DAY AFTER RECEIVING SYNVISC ONE INJECTION, IT HURT ALL DAY AND NIGHT CALLED DOCTOR. PATIENT STARTED TO EXPERIENCE THE SYMPTOMS OF PAIN THE SAME DAY AS THE INJECTION AND THE FOLLOWING WEEKEND IT BECAME MUCH WORSE. IMMEDIATELY HIS BODY REACTED, HIS KNEES WELLED AND WAS IN PAIN, HE COULDN'T WALK FURTHER THAN THE BATHROOM FROM THE BED, EVEN GETTING TO COUCH WAS A SERIOUS ISSUE THEN PATIENT WAS TOLD TO USE ICE AND TYLENOL, HAD TO USE A CANE , TOLD TO GET STEROID SHOT, BUT PATIENT WAS IN SO MUCH PAIN COULD NOT BEAR THE THOUGHT OF GETTING ANOTHER SHOT. THE FOLLOWING TUESDAY AFTER THE SHOT PATIENT STILL COULD NOT DO ANYTHING, THEN WED THE DOCTOR WAS ONLY WORKING HALF DAY AND NURSE TOLD HIM IT WAS A BAD BATCH. ON (B)(6) 2017, PATIENT WAS IN MUCH PAIN WENT TO DOCTOR HAD KNEE DRAINED (ONSET DATE: (B)(6) 2017; LATENCY UNKNOWN) AND CORTISONE AND A SCAN OF HIS KNEE. PATIENT SON DESCRIBED THE KNEE AS LOOKING BRUTAL LOOKING AND HIS FATHER HAVING A FEVER AND CHILLS. IT WAS STATED THAT THE ICE AND TYLENOL THAT WAS RECOMMENDED BY HIS DOCTOR DID NOTHING. PATIENT HAD TO USE A CANE TO WALK. PATIENT'S KNEE BOTHERED HIM THROUGHOUT THE WEEK , PATIENT HAD DIFFICULTY WALKING, HAD PAIN AND KNOT IN THE BACK OF KNEE, REPORTED OF CALF GETTING TIGHT, PAINFUL AND SWOLLEN. THE KNEE THAT WAS DRAINED HAD A LOT OF FLUID COME OUT OF IT. ALSO, LEFT POPLITEAL FOSSA BAKER'S CYST WAS DIAGNOSED IN THE PATIENT. AFTER STERILE PREP WITH BETADINE, 45 CC OF CLEAR SYNOVIAL FLUID WAS ASPIRATED FROM LEFT KNEE WITHOUT DIFFICULTY. THEN 8 CC OF MARCAINE AND 2CC/8,G DEXAMETHASONE WAS INJECTED INTRA-ARTICULARLY TO THE LEFT KNEE. ON (B)(6) 2017, PATIENT WENT BACK TO DOCTOR AS WAS IN STILL IN PAIN, WEEK, HOT, COLD SHAKING THEN A MONTH OUT FROM THE SHOT SYNVISC-ONE, INSIDE OF MOUTH FELT STICKY, RACING HEART, CHEST PRESSURE, LOSS OF BALANCE AND FELT SHOT TERM MEMORY NOT THE SAME, INTENSE BURNING ALL THE WAY DOWN TO LOWER LEG , TIGHTNESS BEHIND KNEE , THIS WAS THE LEFT KNEE, VISION CHANGES, BLURRING, FELT THINGS WOULD DRIFT IN HIS VISION, MOOD SWINGS, DEPRESSED MOOD, EASY UPSET SERIOUS PERSONAL CHANGE (ONSET DATE: (B)(6) 2017, LATENCY UNKNOWN). PATIENT'S SON REPORTED THAT HIS FATHER EXPERIENCED FEVERS, MUSCLE STIFFNESS AND ANXIETY. HE WAS EASILY AGITATED, LACK OF MOBILITY WAS FRUSTRATING. AT NO TIME DID THE INJECTION GIVE HIM ANY RELIEF. IT WAS REPORTED THAT AFTER INJECTION PATIENT HAD MORE OF A DEBILITATING AND WAS IN VERY GOOD HEALTH UNTIL SHOT. IT WAS REPORTED THAT PATIENT HAD A FLAIR REACTION TO SYNVISC ONE. ON AN UNKNOWN DATE, PATIENT REPORTED OF A REACTION WITH SYNOVITIS. COMPANY REVEALED THAT THERE WAS METHYLOBACTERIUM THIOCYANATUM INFECTION IN THE CONTAINED LOT NUMBER OF SYNVISC ONE. PATIENT'S SON REPORTED OF PATIENT HAVING DEMENTIA POST SYNVISC ONE INJECTION. IT WAS STATED THAT PATIENT WENT TO PHYSICAL THERAPY AFTER (B)(6) 2017 AND AFTER THAT POINT THINGS HAD STARTED TO TURN FOR THE WORSE. PATIENT WAS SUPPOSED TO SEE A SURGEON BEFORE HE HAD SHOT HIMSELF. IT WAS STATED OVERALL PATIENT WAS AN OUTGOING PERSON AND HIS DEPRESSED MOOD CHANGE WAS BEYOND ABNORMAL FOR HIM. IT WAS STATED THAT THERE WAS A POINT THAT HE NEEDED HELP TO GET OFF THE FLOOR BECAUSE OF HIS MOBILITY ISSUES. IT WAS REPORTED THAT PATIENT DOCUMENTED IN A NOTE THAT HE WAS HAVING FATIGUE, BREATHING ISSUES, CHEST PRESSURE, COORDINATION AND BALANCE ISSUES, FEELING DEPRESSED AND MOOD SWINGS WITH PERSONALITY CHANGES. PATIENT SON DESCRIBES ALL OF THIS AS BEYOND UNUSUAL FOR HIM. PATIENT SON SAID HE HAD ANXIETY AND HE WAS EASILY UPSET. ON (B)(6) 2017 NIGHT, 44 DAYS AFTER RECEIVING SYNVISC ONE INJECTION, IT WAS STATED THAT PATIENT SHOOT HIMSELF TO DEATH. ON CORRECTIVE TREATMENT: CORTISONE, ICE & PARACETAMOL (TYLENOL), STEROID SHOT FOR PAIN/ HURT ALL DAY & NIGHT; CORTISONE, MARCAINE AND DEXAMETHASONE FOR KNEE DRAINED; CANE FOR MOBILITY ISSUES; NOT REPORTED FOR REST EVENTS OUTCOME: UNKNOWN FOR ALL EVENTS REPORTER CAUSALITY: RELATED FOR ALL EVENTS A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4). AN INVESTIGATION WAS INITIATED AS A RESULT OF AN UNEXPECTED INCREASE IN THE NUMBER OF LABELLED ADVERSE EVENTS RECEIVED FROM THE US MARKET FOR SYNVISC ONE, LOT 7RSL021. THE PRODUCT MET ALL RELEASE TESTING AT TIME OF MANUFACTURE IN JUNE 2017. RETAIN SAMPLES WERE RETESTED DUE TO THE UNEXPECTED INCREASE IN ADVERSE EVENTS. HIGHER THAN EXPECTED ENDOTOXIN RESULTS WERE OBTAINED. IN ADDITION, THE PRESENCE OF MICROBIAL CONTAMINATION WAS ALSO CONFIRMED. THE CAUSE OF THESE EVENTS WAS UNDER INVESTIGATION. ONCE THIS INVESTIGATION WAS COMPLETED, CORRECTIVE AND PREVENTIVE ACTIONS WOULD BE IMPLEMENTED. SERIOUSNESS CRITERION: DISABILITY FOR MOBILITY ISSUES; REQUIRED INTERVENTION FOR DEVICE MALFUNCTION, KNEE DRAINED AND PAIN/ HURT ALL DAY & NIGHT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM THE HEALTHCARE PROFESSIONAL. MEDICAL HISTORY ADDED. TREATMENT DRUGS ADDED AND NEW EVENTS OF DEMENTIA, CALF PAIN , SWELLING AND TIGHTNESS,BAKER'S CYST, HYPERSENSITIVITY REACTION, METHYLOBACTERIUM THIOCYANATUM INFECTION WERE ADDED WITH DETAILS. CLINICAL COURSE UPDATED AND TEXT AMENDED ACCORDINGLY. BASED ON INFORMATION RECEIVED ON (B)(6) 2018, CASE (B)(4) WAS FOUND TO BE DUPLICATE OF (B)(4)HENCE, CASE (B)(4) WAS PREPARED FOR DELETION AND ALL THE RELEVANT INFORMATION WAS MERGED INTO CASE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59087 | SYNVISC ONE | MOZ | MOZ | GENZYME BIOSURGERY (RIDGEFIELD) | 7RSL021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death| O| R| S |