FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1220425
·
Received November 4, 2008
Report
- Report Number
- 3004209178-2008-07168
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 8, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT UNDERWENT SURGICAL REVISION/REPLACEMENT OF THEIR LEADS. THE RIGHT LEAD WAS NO LONGER FUNCTIONAL (UNSPECIFIED MALFUNCTION), AND THE LEFT LEAD HAD MIGRATED. FOLLOWING THE REVISION THE THERAPY WAS WORKING WELL. THE PATIENT WAS AT HOME IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 37742| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| LEAD: MODEL 3777| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| LEAD: MODEL 3777 |