FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 476003
·
Received July 30, 2003
Report
- Report Number
- 6000030-2003-00659
- Event Type
- Malfunction
- Date Received
- July 30, 2003
- Date of Event
- June 25, 2003
- Report Date
- July 7, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PUMP BATTERY DEPLETION. THE PUMP WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANLAYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | EXPLANT: UNK| CATHETER: MODEL 8709, LOT# L69917, IMPLANT: 2000 |