FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 470934
·
Received July 8, 2003
Report
- Report Number
- 6000030-2003-00572
- Event Type
- Other
- Date Received
- July 8, 2003
- Report Date
- July 3, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT HAD THE PUMP AND CATHETER REMOVED DUE TO AN INFECTION. THE DEVICE SYSTEM WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION 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 | 77 YR | Other | CATHETER: MODEL 8709, LOT# J11375R38, IMPL: 2003| EXPLANTED: UNK |