FDA Adverse Event
Injury
Summary report: N
SYNERGY VERSITREL
MDR report key: 1150241
·
Received September 3, 2008
Report
- Report Number
- 9614453-2008-04998
- Event Type
- Injury
- Date Received
- September 3, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 6, 2008
- Manufacturer
- MEDTRONIC SWISS MANUFACTURING FACILITY
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE NEUROSTIMULATOR AND EXTENSION WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. REFER TO MFR REPORT # 9314453-2008-05002.
Description of Event or Problem · 1
IT WAS REPORTED THE ELDERLY PT HAD AN INFECTION AND EVERYTHING APART FROM THE LEAD HAS BEEN REMOVED. THE CURRENT PLAN IS TO REMOVE THE LEAD AND IMPLANT A WHOLE NEW DEVICE SYSTEM WHEN THE INFECTION HAS CLEARED UP. IT IS UNCLEAR WHEN THE ONSET OF THE INFECTION OCCURRED. REFER TO MFR REPORT # 961445320085002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY VERSITREL | LGW | MEDTRONIC SWISS MANUFACTURING FACILITY | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPLANTED| IMPLANTED| EXTENSION MODEL 7489 LOT# NHU017733V| IMPLANTED| EXPLANTED| LEAD MODEL UNK LOT# UNK |