FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1201527
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06677
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- August 25, 2008
- Report Date
- September 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S STIMULATION DEVICE WAS REMOVED THREE DAYS AFTER IMPLANT, DUE TO INFECTION. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
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 | Required Intervention | IMPLANTED| PROGRAMMER MODEL 37743 LOT# NKE105148N| LEAD MODEL 3778 LOT# V131291005| EXPLANTED| IMPLANTED| LEAD MODEL 3778 LOT# V123534007| EXPLANTED |