SYNCHROMED II
Report
- Report Number
- 3007566237-2012-02962
- Event Type
- Injury
- Date Received
- December 10, 2012
- Report Date
- May 8, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11040R05, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J11040R05, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).
(B)(4). ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).
(B)(4).
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD HER CATHETER COMPLETELY REMOVED DUE TO THE BREAK. IT WAS STATED THAT THE PROCEDURE OCCURRED SOMETIME BETWEEN (B)(6). THE PATIENT LATER REQUIRED THE PUMP TO BE SURGICALLY REMOVED DUE TO AN EMERGENCY. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM ON THE SUNDAY PRIOR TO REPORT AND WAS DIRECTLY ADMITTED. SHE HAD PRESENTED WITH A FEVER AND THE PUMP AREA WAS SWOLLEN, BEET RED, AND HOT TO THE TOUCH. IT WAS STATED THAT SHE WAS SEPTIC DUE TO A ¿REALLY BAD INFECTION¿. ¿WOUND VACUUMS¿ AND A ¿PICC LINE¿ WERE USED IN THE TREATMENT OF THE INFECTION. AT THAT TIME, THE PUMP WAS SURGICALLY REMOVED AS THE PATIENT WAS AT RISK OF DYING. IT WAS REPORTEDLY UNCLEAR IF THE INFECTION WAS RELATED TO THE CATHETER REVISION. THE REPORTER SPECULATED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE NEWLY IMPLANTED CATHETER, BECAUSE SHE HAD BEEN RECENTLY HAVING REACTIONS TO THINGS LIKE BAND-AIDS AND LATEX. ADDITIONAL INFORMATION WAS PROVIDED ABOUT PREVIOUS PARTS OF THE EVENT. SHE INITIALLY STARTED HAVING INCREASED PAIN ON (B)(6). IN (B)(6), THE PATIENT¿S PHYSICIAN GAVE THE PATIENT FOUR INJECTIONS INTO THE BACK AND RESULTED IN TWO BROKEN TEETH BECAUSE SHE BIT DOWN SO HARD. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN SCREAMING AND HOLLERING BECAUSE NO ANESTHESIA WAS USED. IT WAS STATED THAT THE HYDROMORPHONE WAS REMOVED FROM THE PUMP AND REPLACED WITH SALINE TO PREVENT NECROTIC TISSUE FROM FORMING. A NURSE PRACTITIONER FELT IT WAS UNSAFE TO LET THE DRUG GO DIRECTLY INTO THE TISSUE THROUGH THE CATHETER BREAK. TWELVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT STILL HAD TWO HOLES IN HER BODY FOLLOWING THE ENTIRE SYSTEM BEING EXPLANTED. IT WAS NOTED THAT THE PATIENT COULD PROBABLY FIT HER HAND IN THE HOLE ON HER RIGHT SIDE AS IT WAS TUNNELING REALLY DEEP. THE REPORTER FELT THAT THE HOLES WERE CAUSED BY ALL OF THE DILAUDID THAT HAD BEEN PUMPING INTO THE TISSUE BECAUSE OF THE BROKEN CATHETER. IT WAS STATED THAT THE PATIENT HAD SOME TISSUE REMOVED IN THE AREA. ADDITIONALLY, THE PATIENT WAS HURTING IN HER FRONT AREA, BUT IT WAS WORSE IN HER BACK AREA. IT WAS REPORTED THAT THE PATIENT HAD TWO INFECTIONS. ONE WAS FOUND TO BE ¿GRAM-NEGATIVE RODS¿ AND THE OTHER WAS A TYPE OF INFECTION THAT WAS TYPICALLY SEEN IN THE BLADDER. IT WAS NOTED THAT ONE INFECTION HAD CAUGHT ON TO THE PAIN PUMP LINE AND HAD BEEN GOING RIGHT UP HER SPINE. IT WAS REPORTED THAT THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL ON THE SUNDAY OF THE PRIOR WEEK. AT THE TIME OF REPORT, THE PATIENT WAS AT HOME, BUT WAS CONTINUING TREATMENT FOR THE INFECTIONS. SHE WAS STILL USING TWO WOUND VACUUMS AND WOULD CONTINUE FOR THE NEXT FIVE TO SIX WEEKS. IT WAS STATED THAT THE PICC LINE HAD BEEN REMOVED, BUT THE PATIENT WAS STILL TAKING CIPRO TO TREAT BOTH INFECTIONS. WHILE THE PICC LINE WAS BEING USED, THE PATIENT WAS BEING FLOODED WITH ANTIBIOTICS TO THE POINT THAT SHE ¿COULDN¿T EVEN HOLD IT¿ AND HAD TO PUT A DIAPER ON. THE PATIENT WAS ALSO TAKING 20MG OXYCONTIN THREE TIMES A DAY AND HYDROCODONE EVERY FOUR HOURS. AT THE TIME OF REPORT, THE PATIENT WAS HAVING A NURSE VISIT HER THREE TIMES A WEEK AND WAS SCHEDULED FOR A SURGERY FOLLOW-UP ON THE UPCOMING FRIDAY. IT WAS REPORTED THAT, FOLLOWING THE CATHETER REPLACEMENT IN (B)(6), THE PATIENT STILL HAD TWO HOLES AT THE END OF HER SUTURE LINE. THE SUTURE LINE HAD RUPTURED ABOUT TEN DAYS AFTER THE SURGERY AND THE PATIENT BLED OUT REALLY BAD. SHE ¿BLED OUT A WHOLE BEACH TOWEL FULL OF BLOOD¿ AND CONTINUED TO BLEED SOME UNTIL THE DAY OF THE EMERGENCY SURGERY. THE REPORTER FELT THAT ANTIBIOTICS SHOULD HAVE BEEN USED PROPHYLACTICALLY AT THAT TIME, BUT THE HEALTHCARE PROFESSIONAL WOULDN¿T ADMINISTER ANY. ADDITIONAL INFORMATION WAS PROVIDED ABOUT PREVIOUS PARTS OF THE EVENT. THE REPORTER SUSPECTED THAT THE CATHETER HAD INITIALLY SEVERED ON (B)(6) WHEN THE PATIENT PICKED UP A DOG. ADDITIONALLY, WHEN THE PATIENT¿S TWO BACK TEETH BROKE, IT WAS STATED THAT THEY WENT BACK INTO HER HEAD, THOUGH THE MEANING OF SUCH WAS UNCLEAR. AT THE TIME OF EXPLANT, THE PUMP CONTAINED SALINE, BUT HAD CONTAINED DILAUDID FOR 12 YEARS.
IT WAS LATER REPORTED THAT THE PATIENT铠PUMP WAS REMOVED AND ONLY A "LEAD REMAINS". IT WAS NOTED THAT THERE IS AN "ABANDONED FRACTURED LEADS" REMAINING IN THE RIGHT PELVIC AND SUBCUTANEOUS SOFT TISSUES AND ALSO WITHIN THE LUMBAR SACRAL INTRATHECAL CANAL. IT WAS REPORTED THAT MRI COMPATIBILITY GUIDELINES WERE REQUESTED. IT WAS NOTED THAT THE AREA TO BE SCANNED WAS THE HEAD, NECK AND BACK REGARDING A VEHICLE ACCIDENT NOT RELATED TO THE DEVICE OR THERAPY. IT WAS REPORTED THAT THE PUMP WAS REMOVED DUE TO INFECTION THAT "ALMOST KILLED" THE PATIENT. IT WAS NOTED THAT THE EVENT OCCURRED IN (B)(6) 2013.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BACK HAD BEEN 'HURTING REALLY BAD' AFTER SHE PICKED UP A 50 POUND DOG ON (B)(6) 2012. A MONTH LATER, THE PATIENT SLIPPED OUTSIDE AND FELL. IT WAS NOT A FALL THAT WOULD DAMAGE OR BROKE HER BONE, BUT HER LOW BACK HAD BEEN IN PAIN. THE PAIN WAS DOWN INTO HER RIGHT LEG AND INTO HER FOOT. THE PATIENT HAD BEEN IN BED FOR FOUR MONTHS NOW. IT WAS NOTED THAT BEFORE THE FELL, SHE WAS VERY ACTIVE, BUT NOW SHE COULD NOT DO ANYTHING. THE PATIENT HAD BEEN GOING BACK AND FORTH FROM HER PRIMARY DOCTOR TO PAIN DOCTOR TO NEUROSURGEONS. THE HEALTH CARE PROFESSIONAL THOUGHT THE PATIENT HAD A BROKE BACK WITH A COMPRESSION FRACTURE OR A HAIRLINE FRACTURE, BUT THE PATIENT FELT THE INJURY WAS IN HER SACRUM. AN X-RAY WAS TAKEN, BUT IT WAS UNCLEAR BECAUSE THE PUMP PLACEMENT WAS BLOCKING THE SACRUM AREA. THE PATIENT'S NEUROSURGEON DIRECTED THE PATIENT TO GO TO PHYSICAL THERAPY, BUT THE PROBLEM WAS NOT RESOLVED. THE PATIENT WENT BACK TO THE NEUROSURGEON A COUPLE OF DAYS PRIOR TO THE DATE OF THIS REPORT AND AN X-RAY WAS DONE. THE X-RAY SHOWED THAT 'THE LINE WAS COMPROMISED.' THE DRUG HAD BEEN 'PUMPED OUT INTO PATIENT'S TISSUE AND MUSCLE.' THE PATIENT WENT TO HER PAIN DOCTOR TWO DAYS PRIOR TO THE DATE OF THIS REPORT. THE DOCTOR WAS NOT PRESENT. THE NURSE PRACTITIONER 'PUT PATIENT UNDER RADIOLOGY' AND TOOK PICTURE. THE PICTURE HAD SHOWN 'THE LINE WAS BAD.' IT LOOKED LIKE 'SOMEBODY HAD CUT OUT A SECTION OF IT.' THE PATIENT WENT TO THE PAIN DOCTOR AGAIN THE FOLLOWING DAY. THE DOCTOR 'INCREASED THE PAIN PUMP.' THE PATIENT WAS TOLD THAT THERE WAS NOTHING WRONG WITH HER AND IT WAS ALL IN HER HEAD. THE PATIENT 'FELT LIKE SHE WAS GOING TO DIE AND SHE WAS HURTING REALLY BAD.' IT WAS NOTED THAT PATIENT'S THYROID HAD QUIT WORKING AND THE PAIN WAS MAGNIFIED 100 TIMES WHEN THE THYROID STOPPED WORKING. DURING THE IMPLANT SURGERY, THE PATIENT REQUESTED A 20 ML PUMP BECAUSE SHE LOST 120 POUNDS, BUT A 40 ML PUMP WAS IMPLANTED. THE PUMP WAS POKING OUT OF HER ABDOMEN AND SHE COULD NOT WEAR JEANS. SHE COULD ONLY WEAR SWEAT PANTS. THE PATIENT WOULD LIKE TO HAVE A DYE STUDY DONE, BUT THE PAIN DOCTOR REFUSED TO DO IT. THE PAIN DOCTOR BELIEVED THAT THE PUMP WAS WORKING, AND HE DID NOT THINK THERE WAS A PROBLEM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT ALSO EXPERIENCED NAUSEA AND BAD HEADACHES. THE PAIN DOCTOR WOULD NOT DO A MAMMOGRAM (AS REPORTED PREVIOUSLY) BECAUSE HE WAS AFRAID THAT THE PATIENT WILL GET AN INFECTION. IT WAS NOTED THAT THE PATIENT HAD VISITED THE DOCTOR ABOUT 20 TIMES SINCE SHE FELL IN (B)(6) 2012. X-RAY PERFORMED SHOWED THAT THE CATHETER WAS DISCONNECTED, BUT THE DOCTOR 'DID NOT BELIEVE THE LINE WAS DISCONNECTED.' THE PATIENT BELIEVED THE DOCTOR WAS 'TRYING TO KILL HER' BY INCREASING THE PUMP, AND THE PATIENT WOULD LIKE THE PUMP TURNED DOWN BECAUSE IT WAS MAKING HER HEAD 'HURT WORSE' AND MORE NAUSEATED. IT WAS ALSO REPORTED THAT THE PATIENT'S NEUROSURGEON WAS WILLING TO REVISE THE CATHETER BECAUSE THE PATIENT NEEDED A BACK SURGERY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT COULD HARDLY WALK. THE PATIENT DID NOT HAVE A CATHETER REVISION DONE YET BECAUSE SHE WAS TOLD THAT SHE COULD 'OVERDOSE AND DIE' IF THE CATHETER WAS FIXED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN AND METALLIC TASTE IN HER MOUTH. SHE ALSO HAD A COMPUTATIONAL TOMOGRAPHY DONE AND IT SHOWED THAT THE CATHETER WAS 'BROKEN.' ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PUMP WAS DELIVERING SALINE. THE PATIENT EXPERIENCED WITHDRAWAL FOR WEEKS AND HAD DEVELOPED NECROTIC TISSUE BECAUSE THE PAIN MEDICATION HAD BEEN 'PUMPING INTO HER TISSUE FOR EIGHT MONTHS.' THE PATIENT WAS TAKING ORAL DILAUDID FOR HER PAIN, BUT SHE WAS NAUSEATED AND SICK FROM THE ORAL MEDICATIONS. IT WAS ALSO REPORTED THAT THE PATIENT HAD THREE SUPERFICIAL INJECTIONS WITH SOME STEROIDS IN HER BACK IN (B)(6) 2012. THE PATIENT FOUND 'CATHETER KINKS IN TWO DIFFERENT' ON THE X-RAY. THE PATIENT DID NOT WALK VERY FAST AND SHE WAS SHORT OF BREATH. SHE HAD PROBLEM SLEEPING AND HAD A LOT OF ANXIETY. XANAX WAS PRESCRIBED. AMBIEN PHENERGAN WAS ALSO PRESCRIBED BECAUSE SHE HAD SOME NAUSEA. THE DOCTOR FELT THAT THE PATIENT HAD A PINCHED NERVE BECAUSE THE PAIN WAS IN HER RIGHT LEG AND INTO HER FOOT. THE PATIENT WAS IN THE EMERGENCY ROOM ON (B)(6) 2013 WITH WITHDRAWAL BECAUSE THE NURSE PRACTITIONER WHO FILLED THE PUMP WAS 'NOT VERY EDUCATED IN PAIN MANAGEMENT' AND SHE DID NOT REALIZE THAT THE HYDROMORPHONE THAT WAS IN THE PUMP WAS '80 TIMES MORE POTENT THAN THE ORAL HYDROMORPHONE.' THE PUMP HAD SALINE IN IT SINCE (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT HAD A DYE STUDY DONE ON (B)(6) 2013. WHEN THE HEALTH CARE PROFESSIONAL INJECTED THE DYE, SHE FELT BURNING IN HER BACK RIGHT WHERE 'THE SWELLING WAS FOUND IN HER BACK' MONTHS AGO. THE PATIENT 'SUFFERED FOR EIGHT MONTHS.' THE PATIENT WAS SO SICK THAT SHE COULD HARDLY RAISE HER HEAD. THE DOCTOR TOOK THE PATIENT OFF ORAL DILAUDID AND PUT HER ON OXYCONTIN 20 MG TWICE A DAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT'S LOWER SPINE 'HAD COLLAPSED.' THE CATHETER HAD BEEN 'LEAKING FOR ALMOST A YEAR.' THE PATIENT HAD A CATHETER REVISION DONE ON (B)(6) 2013. IT WAS NOTED THAT 'ALMOST AN INCH [CATHETER] WAS MISSING. IT WAS JUST FLOATING AROUND SOMEWHERE IN MY BODY [PATIENT].' ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT HAD A SURGERY ON (B)(6) 2013.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN WAS HAD BEEN "LIVING IN HELL" SINCE LIFTING A HEAVY OBJECT IN SEPTEMBER AND FALLING IN OCTOBER. THE PATIENT ALSO REPORTED FEELING SICK AND BEING NAUSEATED DUE TO HER HEALTHCARE PROVIDER (HCP) NOT PRESCRIBING HER PHENERGAN. DUE TO THE NAUSEA, THE HCP HAD TO DECREASE THE PATIENT'S PUMP DOSAGE TO MITIGATE THE NAUSEA. THE PATIENT REQUESTED A MYELOGRAM BUT WAS TOLD BY HER HCP THAT A MYELOGRAM WOULD INCREASE THE RISK FOR INFECTION DUE TO THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
FURTHER INFORMATION RECEIVED AS OF THE DATE OF THIS REPORTED INDICATED THAT THE CATHETER LINE HAD FRACTURED (REPORTED BROKEN PREVIOUSLY) AND THAT THE PATIENT HAD A LOT OF PAIN AND FLUID COLLECTION IN HER BACK. HOWEVER THE PHYSICIAN HAD INSISTED NOTHING WAS WRONG. PER REPORTER THE X-RAY CLEARLY SHOWED THE BREAK BUT HE SAID THAT IT WAS NOTHING; PATIENT HAD VISITED THE HCP ONCE THE PAIN STARTED GETTING WORSE BUT HE WOULD NOT DO ANYTHING. A DYE STUDY WAS DONE IN (B)(6) 2012. THE CATHETER WAS FRACTURED. THE NEUROSURGEON WOULD NOT FIX IT UNTIL PATIENT WAS TITRATED DOWN. HE DID NOT WANT HER TO OVERDOSE ONCE THE CATHETER WAS REPAIRED. THE INFECTION WAS CAUSED BY THE HYDROMORPHONE LEAKING INTO THE TISSUE IN THE BACK. IT HAD STARTED NECROTIZING AND DEGRADING THE TISSUE IN THE AREA WHERE THE CATHETER WAS FRACTURED "IN THE MIDDLE OF HER BACK". HCP REFUSED TO LOWER HER MEDICATION. THE NEUROSURGEON COULD NOT PERFORM THE REPAIR BECAUSE OF IT. PATIENT WAS TAKEN TO THE HOSPITAL AND ALMOST DIED BECAUSE THE INFECTION HAD ALMOST SPREAD TO HER SPINAL CORD, "THAT IS HOW BAD IT WAS". THE INFECTION WAS GRAM NEGATIVE EXACT TYPE OF INFECTION UNKNOWN. CORRECTION: [THE FOLLOWING WAS PREVIOUSLY REPORTED IN MFR REPORT # 3007566237-2013-03094: IT WAS REPORTED THE PATIENT WAS REFERRED FOR EVALUATION AND TREATMENT OF CHRONIC PAIN IN THE LUMBAR AND CERVICAL REGIONS. SHE BEGAN TO HAVE PROBLEMS WITH HER BACK MANY YEARS AGO AND HAD A LUMBAR LAMINECTOMY AND A "C5-C7. SHE HAD "ACDF" IN THE LATE 1980S AND DID WELL FOR A WHILE, BUT THEN IN 1999, HAD A MOTOR VEHICLE CRASH THAT WAS NOT "TERRIBLY SERIOUS" BUT THIS, COMBINED WITH TIME, MADE THE PAIN MUCH WORSE. IN 2002, SHE HAD THE FIRST OF TWO INTRATHECAL PUMPS PLACED. IN 2012, SHE PICKED UP A 50 POUND DOG AND CARRIED HIM SEVERAL TIMES. AFTERWARDS, SHE BEGAN TO HAVE SIGNIFICANT PAIN THROUGHOUT HER BODY, ESPECIALLY IN HER BACK AND LEGS. THE PATIENT HAD PERSISTENT HEADACHES SINCE AND FELT SOMETHING WAS WRONG. SHE HAD DIAGNOSTIC STUDIES AND WORK UP AND WAS REFERRED TO NEUROSURGERY IN THE FALL OF 2012. AN X-RAY REVEALED DEGENERATIVE SPONDYLOSIS, DEGENERATIVE DISK DISEASE, AND "AN APPROXIMATE 2CM SEGMENT OF LUCENCY WHERE THE TUBING DID NOT APPEAR INTACT." THE PATIENT WAS SCHEDULED WITH THE NEUROSURGEON TO HAVE HIM "TAKE A LOOK IN THERE TO SEE IF HE CAN RECONNECT THE CATHETER IN SOME WAY." REMOVING THE CATHETER ENTIRELY WAS ALSO DISCUSSED. THE PATIENT WAS ALSO TAKING ORAL PERCOCET AS WELL, BUT DID NOT FEEL SHE WAS DOING WELL. THE HEALTH CARE PROVIDER (HCP) INDICATED HE ADVISED THE PATIENT OF HIS "GREAT CONCERNS" THAT IF THE CATHETER WAS RECONNECTED IN SOME FASHION AND SHE SUDDENLY BEGAN TO RECEIVE THE PROGRAMMED DOSE OF INTRATHECAL MEDICATION, THAT SHE WOULD BE IN "SERIOUS RISK OF OVERDOSE AND EVEN A LETHAL OUTCOME POTENTIALLY." THE HCP ALSO SPOKE WITH THE NEUROSURGEON HCP AND HIS/HER NURSE WITH THESE CONCERNS AS WELL. THE HCP RECOMMENDED THE PUMP "MORE OR LESS BE STARTED OVER AS FAR AS RE-TITRATION." IT WAS OF NOTE THAT THE SHE TALKED WITH THE HCP ABOUT HER CONCERNS AND DID NOT FEEL HE WAS PARTICULARLY AGGRESSIVE IN INVESTIGATING THE "POSSIBLE PUMP MALFUNCTION." THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND CLONIDINE. ADDITIONAL INFORMATION WILL BE REPORTED IN THIS MFR REPORT HENCEFORTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Hospitalization| L| R |