FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1243714
·
Received November 25, 2008
Report
- Report Number
- 3004209178-2008-07751
- Event Type
- Injury
- Date Received
- November 25, 2008
- Report Date
- October 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S DEVICE WAS REMOVED DUE TO INFECTION. NO DATE OR PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION 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 | LEAD: MODEL 3998| EXPLANTED:| EXTENSION: MODEL 37082| IMPLANTED:| LEAD: MODEL 39565| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081 |