FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1062347
·
Received June 18, 2008
Report
- Report Number
- 3004209178-2008-03317
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- April 1, 2008
- Report Date
- May 20, 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
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF PREEXISTING PAIN SYMPTOMS AND HAD NO STIMULATION. TELEMETRY REVEALED THAT THE NEOROSTIMULATOR WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI), AND THE BATTERY NEEDED TO BE REPLACED. THE PT UNDERWENT REPLACEMENT SURGERY. THE PT OUTCOME WAS REPORTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | LEAD: MODEL 3776| EXPLANTED| LEAD: MODEL 3776| EXPLANTED| PROGRAMMER: MODEL 37742 |