FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1082631
·
Received July 25, 2008
Report
- Report Number
- 2182207-2008-04415
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 30, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO INFECTION. THE NEW PUMP WAS PLACED SUBFASCIAL ALONG WITH A NEW PROXIMAL CATHETER SEGMENT. THE PT WAS GIVEN ANCEF INTRAVENOUSLY DURING SURGERY; THE PUMP POCKET WAS IRRIGATED WITH ANTIBIOTIC SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8596 LOT# N092927017| CATHETER MODEL 8709 LOT# N065828027| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED: |