SYNCHROMED II
Report
- Report Number
- 3004209178-2012-10567
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- January 2, 2014
- 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
- TN, US
- Reporter Occupation
- PATIENT
Narratives
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4)
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
ADDITIONAL INFORMATION WAS REPORTED THAT THE 1ST 3 MONTHS AFTER IMPLANTED, THE INCISION SITE WAS VERY SWOLLEN, AND THE PUMP WAS FLIPPED, AND THE PATIENT DIDN¿T HAVE PAIN RELIEF. THE PATIENT STATED WHEN SHE WAS SITTING ON THE TOILET; THE PUMP WOULD TURN SIDEWAYS. THE PATIENT HAD DYE STUDY WHICH THE PATIENT NEEDED TO FLIP THE PUMP FOR THEM TO DO IT. THE PATIENT HAD A PUMP REVISION, AND THE PATIENT FELT THE PUMP WAS IMPLANTED DEEPER AND STABLE, AND THE PATIENT WAS GETTING PAIN RELIEF.
IT WAS REPORTED THE AREA AROUND PUMP WAS SWOLLEN AND "MOVES AROUND IN THE POCKET AND FLIPS AROUND". IT WAS ALSO REPORTED NEVER HAVING THERAPEUTIC EFFECT. PHYSICIAN TOOK A SYRINGE AND 'TOOK OUT A BUNCH OF FLUID THAT IS AROUND THE PUMP'. A DYE STUDY WAS PERFORMED ON (B)(6)-2012 RESULTS WERE UNAVAILABLE AT DATE OF THIS REPORT. THE DRUG BEING USED IN THE PUMP WAS MORPHINE (UNKNOWN). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING PAIN RELIEF SINCE THE PUMP WAS IMPLANTED IN (B)(6) 2012. THE PUMP SITE WAS SWOLLEN FOR THREE MONTHS AFTER IMPLANT AND IT ¿WOULD NOT GO DOWN.¿ THE PUMP WAS FLOATING AND TWISTING AROUND. WHEN THE PATIENT WOULD SIT ON ANYTHING HARD, THE EXAMPLE SHE GAVE WAS SITTING ON THE TOILET, THE PUMP WOULD TURN SIDEWAYS. THE HEALTHCARE PROVIDER (HCP) ORDERED A DYE STUDY, BUT IN ORDER FOR THEM TO DO THE DYE STUDY THE PATIENT HAD TO FLIP THE PUMP FOR THEM. THE PATIENT¿S PUMP WAS REPLACED (B)(6) 2012 AND IT WAS IMPLANTED DEEPER. THE PUMP FELT MORE STABILIZED. THE PATIENT WENT IN TO HAVE THEIR STITCHES TAKEN OUT (B)(6) 2012 AND A DRAIN WAS PUT IN. THE FLUID COMING FROM THE DRAIN WAS ¿AWFUL LOOKING¿ AND ¿GRAYISH¿ IN COLOR. THE HCP STATED THAT PUMP PROBABLY WAS NOT GOING TO WORK AND THEY WOULD HAVE TO FIGURE SOMETHING ELSE OUT. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PUMP WAS ¿MAYBE¿ INFECTED, BUT THE HCP WAS "TRYING EVERYTHING" BEFORE HAVING TO TAKE IT OUT.
ADDITIONAL REVIEW INDICATED ONLY THE INFORMATION LEADING TO THE PUMP REPLACEMENT ON 2012-(B)(6) PERTAINS TO THIS MANUFACTURER¿S REPORT. UPON FURTHER REVIEW, INFORMATION RELATED TO THE POST-REPLACEMENT NO LONGER APPLIES TO THIS MANUFACTURER¿S REPORT. ALL FURTHER INFORMATION REGARDING THE INFECTION/POST-REPLACEMENT WILL BE REPORTED UNDER MANUFACTURER REPORT #3007566237-2014-01190.
IT WAS LATER REPORTED THAT THE PATIENT HAD AN INJECTION IN HER BACK BECAUSE "IT HAD A HOLE IN IT". THEN IT GOT INFECTED AND SWELLED UP ALMOST LIKE A FOOTBALL AND SNAKED UP HER BACK, SO THEY TOOK IT OUT. IT WAS ALSO STATED THAT THE MORPHINE WASN'T HELPING HIS PAIN AT ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |