SYNCHROMED II
Report
- Report Number
- 3004209178-2013-11880
- Event Type
- Injury
- Date Received
- July 17, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 25, 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11311R33, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).
PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
(B)(4)
IT WAS LATER REPORTED THAT THE CATHETER MOVED. THE PATIENT ¿CAUGHT¿ ((B)(6)) ON (B)(6) 2013. SHE WAS ON ANTIBIOTICS EVERY DAY FOR WEEKS, HOPING IT WOULD GO WAY. TWO WEEKS LATER, THE PATIENT SAW A NEUROSURGEON FOR EMERGENCY SURGERY TO REMOVE THE ENTIRE SYSTEM. THE PATIENT WAS IN THE HOSPITAL FOR TEN DAYS AND, DURING THAT TIME, SHE WAS RECEIVING ANTIBIOTICS THROUGH A PERIPHERAL INTRAVENOUS CENTRAL CATHETER (PICC). IT WAS NOTED THAT THE PATIENT HAD FOUR SURGERIES AND HAD A NERVOUS BREAKDOWN. THE HEALTHCARE PROVIDER (HCP) WOULD NOT IMPLANT THE PATIENT AGAIN BECAUSE SHE HAD (B)(6).
IT WAS REPORTED THE PATIENT HAD LOST ¿SO MUCH¿ WEIGHT THAT THE CATHETER WHERE IT WAS ANCHORED WAS STICKING OUT. THE HEALTH CARE PROVIDER (HCP) MOVED IT/RE-ANCHORED IT DURING THE PUMP REPLACEMENT SURGERY. THEN ON (B)(6) 2013, THE PATIENT HAD TO GO INTO EMERGENCY SURGERY BECAUSE ¿IT WAS LEAKING SPINAL FLUID AND MORPHINE¿ AND HAD A HOLE IN IT. THE PATIENT HAD NOTICED THE SYMPTOMS WHEN HER PATCH ON HER NECK WAS WET SO SHE CALLED HER HCP AND HE HAD TOLD HER TO COME STRAIGHT IN AND THAT WAS WHEN SHE WAS SENT IMMEDIATELY INTO SURGERY. THE SITE HAD BEEN LEAKING ¿JUST A TINY AMOUNT OF SPINAL FLUID¿. IT WAS REPORTED ¿THEY TOOK IT OUT AS MUCH AS THEY COULD WHEN THEY WENT IN BECAUSE IT WAS LEAKING. THEY TOOK IT OUT OF MY BACK. THEY DIDN¿T REOPEN MY STOMACH WHERE MY PUMP IS¿. IT WAS REPORTED THE PATIENT WAS CURRENTLY A ¿CRITICAL MASS HERE RIGHT NOW¿ AND WAS WAITING TO ¿GET MY SURGERY AND I AM IN PIECES¿. THE PATIENT WAS WAITING TO HAVE SURGERY ¿AS SOON AS POSSIBLE TO GET IT HOOKED BACK UP BECAUSE MY NERVES ARE SHOT¿. IT WAS REPORTED THE HCP PLANNED TO TAKE OUT THE OLD CATHETER AND PUT A WHOLE NEW CATHETER IN. IT WAS STATED, ¿THIS TIME THEY¿VE GOT TO GO INTO MY PUMP TO GET THAT PART OUT AND GO INTO MY BACK AND REPLACE ALL OF IT¿. IT WAS NOTED, ¿YOU JUST DON¿T KNOW WHEN YOU¿VE BEEN ON MORPHINE FOR DECADES AND YOU ARE WITHOUT ANYTHING WHAT YOU GO THROUGH: MY PAIN, MY MUSCLE SPASMS, MY LEGS ARE DRAWING UP, MY FEET ARE TURNING TO THE INSIDE AND GOING STRAIGHT UP, MY DAUGHTER IS RUBBING ME DOWN WITH ALCOHOL WITH A WASHCLOTH WITH SOAP TO GET THEM TO STOP. I CAN¿T COPE¿. THE PATIENT HAD TALKED TO HER HCP ON THE DAY OF THIS REPORT AND TOLD THEM TO PLAN THE SURGERY ¿AS SOON AS POSSIBLE¿ BECAUSE SHE COULDN¿T WAIT ANY LONGER. IT WAS NOTED ¿I WAS GOING TO BE IN THE HOSPITAL ANYWAY¿. THE PATIENT NOTED THAT THEY BELIEVED WHEN YOU GET YOUR THIRD PUMP THAT THE CATHETER SHOULD BE REPLACED AS WELL AND IT WAS NOTED ¿BECAUSE THAT TUBING GETS OLD. I¿VE WORKED WITH IT AND YOU HAVE TO REPLACE IT. IT DETERIORATES¿. THE DEVICE SYSTEM WAS CURRENTLY USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS LATER REPORTED THAT THE PATIENT FELT THAT THE LIFETIME OF THE CATHETER OR LONGEVITY OF THE CATHETER SHOULD BE LISTED ON LABELING SO THAT IT HELPED TO EDUCATE HEALTHCARE PROVIDERS (HCP) TO PREVENT WHAT HAPPENED TO HER. THE PATIENT HAD TO HAVE MULTIPLE SURGERIES WITH HER MORPHINE PUMP AND THOUGHT THAT BECAUSE OF THE 4 SURGERIES AFFILIATED WITH THE PUMP, SHE CONTRACTED ((B)(6)). IT WAS NOTED THAT THE PATIENT CONTRACTED (B)(6) BETWEEN THE 3RD AND 4TH SURGERIES, BETWEEN (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD 2 PREVIOUS PUMPS FOR YEARS AND THEY DIDN¿T CHANGE THE CATHETER AND WHEN THEY PUT THE THIRD PUMP IN, THE CATHETER BURST. IT CATHETER BURST 3 DAYS AFTER THE PUMP WAS PUT IN AND ¿IT HAD TO BE SOME DETERIORATION FROM WHEN THE PUMP WAS PUT IN.¿ THREE DAYS AFTER THE 3RD PUMP REPLACEMENT SURGERY, THE PATIENT HAD EMERGENCY SURGERY TO REMOVE THE CATHETER. ABOUT A MONTH LATER, IN (B)(6) 2013, THEY WENT BACK IN AND PUT THE CATHETER IN AND THAT¿S WHEN THE PATIENT CONTRACTED (B)(6). ON (B)(6) 2013, THE PATIENT HAD TO HAVE THE ENTIRE SYSTEM REMOVED BECAUSE OF (B)(6). THE PATIENT QUESTIONED IF IT WAS ¿PROCEDURE¿, AFTER ALL OF THOSE YEARS, TO HAVE THE CATHETER REPLACED PRIOR TO THE 3RD PUMP REPLACEMENT. THIS MIGHT HAVE PREVENTED THE THINGS THAT OCCURRED. THE PATIENT COULD HAVE DIED AND COULDN¿T STAND THE PAIN FROM HAVING ALL OF THAT STUFF REMOVED AT ONE TIME. AT THE TIME OF THIS REPORT, THE PATIENT NEEDED A NEW REPLACEMENT AND COULDN¿T HAVE THAT BECAUSE SHE HAD (B)(6) IN HER BODY. THE PATIENT WAS ON SO MANY DRUGS AND ALMOST WENT CRAZY FROM NOT HAVING THE PUMP AND SUDDENLY HER SYSTEM WENT HAYWIRE. THE PATIENT WAS ON OVER 13 CONTROLLED SUBSTANCES IN ONE MONTH AND IT WAS DURING THE HEAT OF THE SUMMER, SO IT WAS ¿SORT OF CRAZY.¿ THE PATIENT FELT THAT AFTER BEING IMPLANTED FOR 11 YEARS AND THE DRUG BEING PUT IN AND THROUGH IT, THE CATHETER SHOULD BE EXAMINED SO THAT OTHERS DID NOT HAVE TO ENDURE HER SAME ISSUE. THE PATIENT THOUGHT THAT, AFTER A CERTAIN AMOUNT OF YEARS, ¿OF COURSE THINGS WEAR OUT¿, ESPECIALLY THE TUBING THAT THE CATHETER WAS MADE OUT OF. AFTER 11 YEARS, A PRACTICE MIGHT BE TO CHECK THE CATHETER AND REPLACE IF APPROPRIATE. IT WAS NOTED THAT, BECAUSE OF THE (B)(6), THE PATIENT COULDN¿T GET A KNEE REPLACEMENT SURGERY SHE HAD. IT WAS ALSO NOTED THAT THE PATIENT WAS (B)(6) AND IF SHE NEEDED A PACEMAKER THAT THIS WOULD AFFECT HER IN THE FUTURE. IT WAS NOTED THAT THE DRUG CONCENTRATION WAS CHANGED OVER THE LIFE OF THE PUMP.
ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) DID NOT KNOW THE LOCATION OF THE CATHETER ISSUE. THE CATHETER WAS REPLACED. IT WAS REPORTED THE PATIENT HAD DEVELOPED AN INFECTION/DRAINING IN THEIR LOWER THORACIC SPINE AREA WHERE THE ENTRY OF THE NEW CATHETER WAS. THE PATIENT DEVELOPED THE "DRAINING" AFTER THE SUTURES WERE TAKEN OUT. THE PATIENT WAS PUT ON ORAL ANTIBIOTICS FOR 10 DAYS. THE HCP HAD SPOKEN TO THE PATIENT ON (B)(6)2013 AND THE PATIENT WAS DOING WELL. THE PATIENT HAD NOT HAD ANY DRAINAGE FOR THE LAST GIVE DAYS. IT WAS LATER REPORTED THAT THE CATHETER WAS DISPOSED OF AND WOULD NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331224 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R |