FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3202812
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04775
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- September 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A SEROMA AT PUMP SITE. THE PATIENT¿S PUMP STUCK OUT SINCE THE PATIENT WAS THIN, AND IT HURT TO WEAR A SEAT BELT. THE PATIENT REPORT THAT SHE HAD A ¿PORT-A-CATH¿, AND SHE WAS ABLE TO BUY A CUSHION TO HELP. THE HEALTH CARE PROVIDER WAS GOING TO TRY AN ABDOMINAL BINDER ONCE THE SEROMA WENT AWAY. THE PATIENT STATED THE HEALTH CARE PROVIDER WANTED TO PUSH THE FLUID OUT. THE PATIENT HAD FAILED BACK SURGERY AND HAD DAMAGED HER LEFT SCIATIC NERVE AND HER LEFT FOOT WAS NUMB AND TINGLING. THE PATIENT STATED SHE WAS DOING GREAT WITH PUMP. THE DRUG DELIVERED IN THE PUMP WAS PRIALT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302037 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR | Hospitalization| R |