FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2960989
·
Received February 14, 2013
Report
- Report Number
- 6000030-2013-00027
- Event Type
- Injury
- Date Received
- February 14, 2013
- Report Date
- January 16, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L58361, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S PUMP "QUIT WORKING." THE PATIENT WENT INTO SEVERE WITHDRAWALS AND WAS NEARLY "KILLED." IT WAS NOTED THAT THE BATTERY HAD DIED ON ONE OF THE PATIENT'S PUMPS, BUT IT WAS UNCLEAR WHICH ONE. THE DRUG USED IN THIS SYSTEM WAS DEMEROL.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER WAS REPLACED IN 2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64377 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8617L-18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Required Intervention |