SYNCHROMED II
Report
- Report Number
- 3004209178-2013-07428
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. THE PATIENT WAS GIVEN 100MG OF BACLOFEN AND WAS "GOOD" FO R SEVEN DAYS. ON THE EIGHTH DAY, THE PATIENT REPORTEDLY HAD TROUBLE SLEEPING, WAS NAUSEATED, HAD CHEST PALPITATIONS, AND WAS JITTERY. THE PATIENT WAS TOLD TO GO TO THE EMERGENCY ROOM. THE DOSAGE IN THE PUMP WAS THEN DECREASED TO 50 AND SHE WAS GIVEN ANTI-NAUSEA ME DICATIONS. TWENTY FOUR HOURS LATER SHE HAD SPASTICITY RETURN. THE PATIENT ALSO EXPERIENCED DRY HEAVES, RINGING IN THEIR EARS, FOGGINESS, BLURRED VISION, TROUBLE WITH TRANSFERS AND TWISTING, FRUSTRATED AND DEPRESSED, LEGS WERE TOTALLY FLACCID, AND DID NOT SLEEP FOR TWO WEEKS DUE TO INSOMNIA. THE PATIENT ALSO EXPERIENCED FORGETTING WHAT SHE WAS SAYING, TIGHTNESS IN THE RIBS, AND WAS AT A SPASTICITY LEVEL OF A NINE OR EIGHT. IT WAS NOTED PRIOR TO THE PUMP THE SPASTICITY WAS A TEN. THE PATIENT WAS WEAK, DEHYDRATED, AND NOTED THIS WAS AFFECTING HER PERSONAL LIFE. IT WAS NOTED THE PATIENT HAD THOUGHT THEIR BODY WAS "LIKE INTO A WITHDRAWAL" BECAUSE WITHIN TWENTY FOUR HOURS "SHE TOLD ME I WAS GOING TO START SEEING SOME SPASTICITY. SPASTICITY IS BACK TO EXACTLY WHAT IT WAS BEFORE I EVEN HAD THE IMPLANT." THE PATIENT HAD AN APPOINTMENT WITH HER HEALTH CARE PROVIDER ON "(B)(6)." IT WAS LATER REPORTED HAVING THE PUMP IMPLANTED HAD BEEN NOTHING BUT A "NIGHTMARE" FOR THE PATIENT. IT WAS NOTED THE PUMP HAD BEEN NOTHING "THEY PROMISED." THE PATIENT EXPERIENCED SIDE EFFECTS LIKE SHE DID WITH THE ORAL BACLOFEN. IT WAS REPORTED EIGHT DAYS AFTER THE PUMP IMPLANT, THE PATIENT ENDED UP IN THE EMERGENCY ROOM FOR SEVEN HOURS WITH A SEVERE DRUG REACTION WHICH INCLUDED RINGING IN THE EARS, BLURRED VISION, HEADACHE, NAUSEA, INSOMNIA, LACK OF APPETITE, "YOU NAME IT." SINCE "(B)(6)" THE PATIENT HAD REACTIONS EVERY MONTH, "I WOULD HAVE ONE WEEK OF SEVERE REACTION; THE NEXT WEEK GAIN MY STRENGTH BACK, I WOULD BE LUCKY IF I HAD SEVEN TO TEN DAYS OF A MONTH THAT I ACTUALLY COULD AT LEAST FUNCTION A LITTLE BIT." THE PATIENT HAD BEEN TOLD TO NOT "JUMP THE GUN" SO SHE WAITED UNTIL "(B)(6)" HOWEVER, THE SIDE EFFECTS "KEPT KICKING IN" AND WERE COMING MORE FREQUENTLY. THE PATIENT WAS REPORTEDLY, "COMATOSE FOR PRACTICALLY A YEAR." IT WAS STATED, "PEOPLE ARE WALKING AROUND WITH 1,200 MCG, THEY HAD ME AT A HUNDRED AND I WENT INTO AN OVERDOSE." IT WAS NOTED FROM 2012 TO PRESENT; THE PATIENT HAD BEEN COMPLAINING ABOUT THE SIDE EFFECTS AND HAD BEEN TOLD IT WAS "NORMAL." THE PATIENT'S HEALTH CARE PROVIDER (HCP) HAD TOLD THE PATIENT "I'VE NEVER COME ACROSS SOMEBODY SO SENSITIVE TO MEDICATIONS AS YOU." THE PATIENT "COULDN'T FUNCTION" AND FOR THE PAST TWELVE MONTHS THE PUMP HAD DECREASED HER QUALITY OF LIFE. WHEN THE PATIENT HAD CALLED THEIR HCP PRIOR TO BEGINNING TO WEAN THE PATIENT OFF THE MEDICATION, THEY HAD WANTED HER TO WAIT UNTIL "(B)(6)" BUT THE PATIENT WAS "SO SICK," COULDN'T EAT, COULDN'T SLEEP, COULDN'T DRIVE, AND WAS SEVERELY DEPRESSED. THE PATIENT'S DOSAGE HAD BEEN 57 MCG, "THAT'S HOW SENSITIVE I WAS." THE PATIENT HAD QUESTIONED IF HER HORMONES FROM MENOPAUSE WERE A FACTOR CAUSING THE SYMPTOMS. THE REPORTER LATER NOTED THE SYMPTOMS THE PATIENT HAD EXPERIENCED "DIDN'T REQUIRE ANY EMERGENCY AMBULANCE OF ANYTHING OF THAT NATURE." THE PATIENT HAD NOT HAD A PUMP ADJUSTMENT SINCE "(B)(6)" AND IT WAS NOTED BECAUSE "I DON'T REALLY NEED TO GET INTO THIS WHOLE THING, THE BOTTOM LINE IS I'M GETTING WEANED OFF OF IT. I'VE BEEN STARTING TO GET WEANED OFF OF IT SINCE (B)(6)." SINCE THE PATIENT HAD BEEN STARTED TO BE WEANED, THE NAUSEA, INSOMNIA, LACK OF APPETITE, BLURRED VISION AND RINGING IN THE EARS WERE GONE. "THEY HAD TRIED TO TELL ME IT WASN'T THE PUMP, BECAUSE I HADN'T BEEN ADJUSTED." WITHIN TWENTY FOUR TO FORTY EIGHT HOURS AFTER THE MEDICATION WAS DECREASED THE PATIENT FELT "75 PERCENT" BETTER. IT WAS NOTED THE PATIENT'S SPASTICITY HAD BEEN THE SAME. THE PATIENT HAD BEEN DECREASED EVERY SEVEN DAYS SINCE THE INITIAL DECREASE DOWN TO THE LOWEST RATE POSSIBLE. IT WAS NOTED, "EVERYTHING IS FINE. I'M DOING EXTREMELY WELL RIGHT NOW. WE'VE COME TO A SOLUTION THAT THE PUMP IS NOT WORKING FOR ME." IT WAS LATER REPORTED THE PATIENT'S SYMPTOMS OF NAUSEA AND THE SLEEP ISSUES WERE BOTH DEALT WITH USING ORAL MEDICATIONS. THE SYMPTOMS IMPROVED/RESOLVED AND THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND INDICATED THAT WHEN THE PUMP WAS IMPLANTED THE PATIENT HAD ISSUES WITH THOUGHT PROCESSING AND VOMITING. SHE LIVED ON (B)(6) AND LETTUCE FOR 18 MONTHS AND DROPPED 20 POUNDS. IT WAS NOTED THAT THE PATIENT WAS INDEPENDENT BEFORE THE PUMP AND WHEN THE PUMP WAS IMPLANTED SHE WAS COMPLETELY DEPENDENT. THE PATIENT WENT TO THE EMERGENCY ROOM IN (B)(6) 2012 AND THE DOSE WAS REDUCED FROM 100MCG TO 50MCG AND SHE GOT TIGHT AGAIN. THE PATIENT WAS THEN SEEN BY THE NEUROLOGIST AND THE DOSE WAS INCREASED TO 52MCG. EACH TIME THE PUMP WAS INCREASED OR DECREASED IT TOOK THE PATIENT'S BODY SEVEN DAYS TO ADJUST. THE PATIENT HAD ONE GOOD WEEK OUT OF EVERY MONTH AND THE REST OF THE WEEKS SHE FELT LIKE CRAP AND COULD NOT LEAVE THE HOUSE. OVER 6 MONTHS, THE PUMP WAS WEANED DOWN AND THE PATIENT HAD SALINE IN HER PUMP. SHE USED ORAL BACLOFEN AND VALIUM TO MANAGE HER SPASTICITY. ON (B)(6) 2014, THE PUMP WAS EXPLANTED AND THE CATHETER WAS LEFT IMPLANTED. THE PATIENT REPORTED THAT PRIOR TO THE PUMP SHE USED ESTROGEN PATCHES DURING MENOPAUSE, BUT THROUGH BLOOD WORK SHE LEARNED THAT SHE HAD COAGULATION ISSUES AND HAD TO DISCONTINUE THE PATCHES BEFORE THE PUMP WAS IMPLANTED. IT WAS NOTED THAT THE TRIAL WENT WELL AND THE PATIENT HAD GOOD SYMPTOM REDUCTION. DURING THE TRIAL THE EFFECT OF THE BACLOFEN LASTED ONE FULL DAY. THE PATIENT FURTHER REPORTED THAT THE BACLOFEN "ORALLY AND INTRATHECALLY NEVER AGREED WITH HER."
IT WAS FURTHER REPORTED, AS SUMMARIZED, THE PATIENT REPORTED THAT SHE EXPERIENCED NAUSEA, TACHYCARDIA, INSOMNIA, "JITTERS", DRY HEAVES, AND COGNITIVE IMPAIRMENT SHORTLY AFTER THE PUMP IMPLANT IN (B)(6) 2012. THE PATIENT WAS STARTED AT 100 MCG/DAY OF INTRATHECAL BACLOFEN FOLLOWING SURGERY AND THE DOSE WAS REDUCED TO 50 MCG/DAY WHEN PATIENT PRESENTED WITH SYMPTOMS. THE PATIENT WAS DOSED BETWEEN 50 AND 65 MCG/DAY IN (B)(6) 2012 WITH PERSISTENT SIDE EFFECTS OF NAUSEA, TACHYCARDIA AND INSOMNIA AS THE DOSE WAS ESCALATED. A PHYSICIAN PROGRAMMED THE PATIENT AT 50 MCG/DAY IN (B)(6) 2013 FOR ONE YEAR. IT WAS THEN DETERMINED TO FILL THE PATIENT'S PUMP WITH NORMAL SALINE AND PUMP WAS STOPPED IN (B)(6) 2013 UNTIL THE PRESENT DAY. THE PATIENT ALSO EXPERIENCED AN ALTERED MENTAL STATUS AND HEADACHE. IT WAS UNKNOWN AT THE TIME OF THE REPORT IF THERE WAS ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED. REPORTEDLY, THERE WAS NO ALLEGED PRODUCT ISSUE AND THE DEVICE WAS EXPLANTED. IT WILL NOT BE RETURNED AS THE CUSTOMER REFUSED. THE EVENT DATE WAS NOW REPORTED AT APRIL 17, 2012. AT THE TIME OF THIS REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY.
ADDITIONAL INFORMATION RECEIVED REPORTED DUE TO THE SIDE EFFECTS THE PATIENT HAD BEEN BEDRIDDEN FOR TWELVE MONTHS AND IT HAD BEEN A "COMPLETE NIGHTMARE". THE PATIENT STILL WISHED SHE HAD NEVER HAD THE PUMP AND IT HAD DECREASED HER QUALITY OF LIFE. THE PATIENT'S HEALTH CARE PROVIDER (HCP) HAD KEPT DISMISSING HER. THE PATIENT "THOUGHT HER SPASTICITY WAS EXACERBATED WITH HER MENOPAUSE AND SHE WAS TALKED INTO THE PUMP". ALL OF THE PATIENT'S PROBLEMS STARTED EIGHT DAYS AFTER THE PUMP IMPLANT AT WHICH TIME AS PREVIOUSLY REPORTED SHE WENT TO THE EMERGENCY ROOM (ER) DUE TO A REACTION FOR SEVEN HOURS AND THE MEDICATION WAS DECREASED FROM "100 - 50". THE PATIENT REPORTEDLY THEN WENT INTO WITHDRAWAL "AGAIN ON (B)(6). IT WAS REPORTED IN JUNE THE PATIENT HAD A DOSE OF "52- 62" AND THE HCP INCREASED THE MEDICATION EVEN THOUGH THE PATIENT TOLD HIM NOT TO. AFTER THE THIRD DAY ALL OF THE PATIENT'S SIDE EFFECTS GOT WORSE AND IT FELL ON A WEEKEND. THE HCP WASN'T THERE AND THE PATIENT DIDN'T WANT TO GO TO THE EMERGENCY ROOM. THE HCP HAD THE PATIENT WAIT UNTIL TUESDAY AT 11:00 A.M. THE PATIENT REPORTEDLY HAD A REACTION AND SEVEN DAYS LATER SHE TOLD THE HCP SHE WOULD BE BACK. THE HCP THEN DROPPED THE PATIENT DOWN TO "5" AND SHE FELT BETTER. IT WAS REPORTED THEN IN JULY/AUGUST THE DOSE WAS AT "52" IN AUGUST THE HCP THEN LOWERED THE DOSE TO 50 THROUGH OCTOBER. THE HCP THEN WENT DOWN 15 MICROGRAMS TO 35 AND WITHIN TWENTY FOUR HOURS THE PATIENT'S DIZZINESS, TACHYCARDIA AND WERE GONE. IT WAS THEN REPORTED IN MARCH IT TOOK THE PATIENT THREE HOURS TO GET OUT OF BED, SHE WOULD SIT THERE AND EAT DRY CRACKERS AND LETTUCE. THE PATIENT REPORTEDLY DID THAT FOR TWELVE MONTHS. IT WAS REPORTED EVER MONTH THE PATIENT HAD TWO GOOD WEEKS AND TWO BAD WEEKS. IN MARCH THE PATIENT WAS SICK EVERY DAY. IT WAS REPORTED ON (B)(6) "DOSE OF 24" THROUGH OCTOBER. THE TIMEFRAMES OF THE REPORTED EVENTS WAS NOT CLEARLY SPECIFIED AND THE REPORTER WAS A POOR HISTORIAN IN TERMS OF WHAT WAS RELATED TO THE DRUG EFFECTS.
THIS EVENT WAS PREVIOUSLY CAPTURED AS ITS OWN EVENT [IT WAS REPORTED THE PAST WEDNESDAY FROM THE REPORT DATE THE "ALARM STARTED TO RING". IT WAS GOING OFF ALL DAY THE DAY PRIOR TO THE REPORT DATE AND THE PATIENT WAITED FORTY FIVE MINUTES AT THE HEALTH CARE PROVIDER (HCP) OFFICE AND THE HCP REPORTEDLY ASKED THE PATIENT "WHAT ARE YOU HERE FOR? AT 11:30 P.M. THE NIGHT PRIOR TO THE REPORT DATE THE PATIENT NOTICED THE ALARM WAS FROM HER PUMP. IT WAS REPORTED THE PATIENT WAS PARALYZED FROM HER CHEST DOWN BUT WAS SELF-SUFFICIENT HOWEVER SHE WAS EXHAUSTED FROM NOT SLEEPING DUE TO THE ALARM. IT WAS NOTED THE PATIENT HAD SPASTICITY FOR EIGHTEEN YEARS AND WAS PREGNANT TWICE WHILE PARALYZED, NO FURTHER CLARIFYING INFORMATION WAS PROVIDED REGARDING THE COMMENT. AT 2:00 P.M. ON THE REPORT DATE THE PATIENT WENT INTO THE HCP AND THE HCP WAS "BAFFLED" THAT THE ALARM WAS GOING OFF BECAUSE HE HAD TURNED THE DEVICE OFF. THE HCP HAD SAID HE COULD SILENCE THE ALARM OR TURN HER BACK ON. THE HCP PLANNED TO CALL TECHNICAL SUPPORT. THE DEVICE SYSTEM CURRENTLY DELIVERED SALINE AND HAD PREVIOUSLY DELIVERED GABLOFEN.]. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER (#3004209178-2013-07428). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD GABLOFEN IN HER PUMP IN (B)(6) 2013 THAT STAYED IN THE PUMP FOR SIX MONTHS. IT WAS REPORTED THE BACLOFEN WAS THEN WITHDRAWN IN (B)(6) 2013 AND SALINE WAS INJECTED BECAUSE THE "PUMP JUST DIDN'T AGREE WITH HER, SO THEY STOPPED THE PUMP". IT WAS REPORTED ON (B)(6) 2013 THE PUMP WAS STOPPED AND SALINE WAS PUT IN IT. AS PREVIOUSLY REPORTED PRIOR TO THE REMOVAL OF BACLOFEN THE PATIENT WAS WEANED DOWN DUE TO SIDE EFFECTS WITH THE MEDICATION. IT WAS REPORTED THE PATIENT HAD THOUGHT SHE WAS GOING CRAZY BECAUSE SHE HAD THOUGHT THE HEALTH CARE PROVIDER (HCP) HAD SHUT THE PUMP OFF BUT HE HAD NOT, HE HAD ONLY STOPPED IT AND 48 HOURS LATER THE PUMP WAS ALARMING ON (B)(6) 2013. THE HCP WAS "BAFFLED" WHY THE ALARM WAS GOING OFF AT THAT TIME UNTIL HE RECEIVED ASSISTANCE FROM THE DEVICE MANUFACTURER. THE PLAN OF ATTACK WAS TO RUN THE PATIENT'S PUMP FOR SIX MONTHS TO SEE HOW SHE DID WITH THE SPASTICITY. IT HAD NOW AS OF (B)(6) 2013 BEEN A MONTH AND FOUR DAYS AND THE SPASTICITY WAS "ABOUT THE SAME AS IT WAS WITH 24MCG, BUT MAYBE A SMIDGEN MORE IN THE MORNING". HOWEVER, AFTER THE PATIENT WOULD GET UP AND MOVE AROUND IT WAS "ABOUT THE SAME" WITH THE PUMP OFF. IT WAS NOTED IF THE PATIENT HAD A FLIP A COIN ON IF SHE WOULD TURN THE PUMP BACK ON, IT WOULD BE A NO BECAUSE IT MADE HER SICK FOR TWELVE MONTHS. THE PATIENT'S HCP REPORTEDLY "JUST DISMISSES HER" AND THE PATIENT BELIEVED SHE COULD CONTINUE WITH THE PLAN AND SEE HOW HER BODY REACTED IN THE WINTER. IT WAS NOTED COLD INCREASED HER SPASTICITY BUT SHE WANTED TO SEE IF SHE COULD TOLERATE THE COLD WITHOUT THE PUMP RUNNING AND WITH JUST TAKING MUSCLE RELAXERS ORALLY. THE PATIENT HAD BEEN TAKING VALIUM PRIOR TO HAVING THE PUMP. THE PATIENT WAS SUPPOSED TO FOLLOW UP WITH HER HCP ON THE SUPPLEMENTAL REPORT DATE BUT IT WAS 29 DEGREES AND THE PATIENT AS HAVING ISSUES WITH HER LIFT IN HER VAN AND DID NOT WANT TO GET STUCK IN A SITUATION BECAUSE SHE WAS PARALYZED FROM THE CHEST DOWN AND WOULD BE BY HERSELF. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204266 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Other| R |