SYNCHROMED II
Report
- Report Number
- 3004209178-2013-00329
- Event Type
- Injury
- Date Received
- January 9, 2013
- Report Date
- December 12, 2012
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION REPORTED THAT THE DEVICE ¿OBVIOUSLY¿ HADN¿T FUNCTIONED. IT WAS THEN STATED IT HAD BEEN EMPTY FOR THREE YEARS, IT WAS THEN STATED A HEALTHCARE PROVIDER (HCP) TOOK ALL THE MEDICINES OUT, NO DATE WAS PROVIDED. IT WAS THEN NOTED THAT A DOSE ADJUSTMENT HAPPENED, AGAIN, NO DATE OF ADJUSTMENT WAS PROVIDED, IT WAS STATED ¿SO HE SAID IT'S REALLY UP WAY TOO HIGH AND WHEN IT TURNS DOWN, I SAID IT COULD TURN OUT 2. HE TURNS IT DOWN TO 15 THEN HE WENT ON VACATION, AND IT WASN'T FILLED FOR TWO WEEKS BECAUSE HE DIDN'T LEAVE A DOCTOR'S REFILL.¿ IT WAS NOT CLEAR WHAT WAS MEANT BY THAT. IT WAS ALSO STATED ¿IT'S KILLING ME (INAUDIBLE) ALL THE WIRES ARE LOOSE,¿ ¿THEY KNOW ALL THOSE FOR THREE YEARS AND THEY JUST LEFT IT THERE EVEN WHEN I HAVE IT FOR LONG TERM. THEY JUST LEFT IT LIKE THAT, YOU KNOW, AND THAT'S WELL, YOU KNOW, HE MADE ME THE DOCTOR THAT PUT IN MADE ME SIGNED AN AFFIDAVIT SAYING THAT HE WOULDN'T TREAT ME WITHOUT THE MORPHINE PUMP BEING PUT IN.¿ AGAIN, NO DATE WAS REPORTED, IT WAS UNCLEAR IF THEY WERE TALKING ABOUT THE CATHETER OR SOMETHING ELSE. THE PATIENT WAS ¿VERY TIRED.¿
ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP MALFUNCTIONED AND "RUINED HER LIFE." IT WAS NOTED IT HAD NOT WORKED IN 4 YEARS AND SHE DOES NOT HAVE THE INSURANCE TO GET THE PUMP REMOVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S PUMP WAS REMOVED ON (B)(6) 2014. IT WAS NOTED THE PATIENT HAD BEEN SUFFERING SINCE 2004 BECAUSE OF THE PUMP. IT WAS FURTHER REPORTED THE DOCTOR "COULD NOT SALVAGE" THE RECENTLY REMOVED PUMP OR CATHETER TO SEND BACK IN FOR ANALYSIS.
IT WAS LATER REPORTED THAT THE PATIENT HAD HER STAPLES REMOVED THE WEEK PRIOR TO THIS REPORT ON (B)(6) 2014.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S CURRENT HEALTH CARE PROVIDER (HCP) HAD NO IDEA WHY THE PUMP WOULD HAVE ALARMED IN 2007. IT WAS NOTED THE PATIENT HAD ONLY BEEN SEEN AT THE HCP'S OFFICE FOR A LITTLE OVER A YEAR. THE HCP REFERENCED THE PATIENT'S PREVIOUS HCP'S RECORDS AND REPORTED THAT ACCORDING TO THE PROBLEM LIST THAT HCP HAD SENT OVER, AROUND A YEAR OR SO AFTER THE PUMP WAS PLACED; IN (B)(6) 2009 THE PATIENT HAD MISSED A REFILL AND COMPLAINED OF PAIN. IT WAS NOTED THERE WERE NO OTHER REFERENCES ELSEWHERE THAT THIS HAD BEEN AN ONGOING ISSUE OR THAT IT REQUIRED INTERVENTIONS EXCEPT FOR FILLING THE PUMP. THE MEDICATION BEING ADMINISTERED VIA THE DEVICE SYSTEM WAS NOT AVAILABLE IN THE HCP RECORDS.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. ONE YEAR AND THREE MONTHS AFTER THE PUMP HAD BEEN IMPLANTED, THE PATIENT WANTED THEIR HEALTHCARE PROVIDER TO "GO IN AND GET IT EITHER FIXED OR PUT IN A NEW ONE" BECAUSE "IT DIDN'T SEEM TO BE WORKING." THE HCP DECLINED TO REPLACE IT AND INDICATED THAT THE PUMP WAS WORKING. THE PATIENT NOTIFIED THEIR HCP THAT THE ALARM HAD BEEN GOING OFF EVERY HOUR FOR ABOUT A YEAR AND A HALF. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12267 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Required Intervention |