FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1000055
·
Received February 15, 2008
Report
- Report Number
- 3004209178-2008-00690
- Event Type
- Injury
- Date Received
- February 15, 2008
- Date of Event
- January 15, 2008
- Report Date
- January 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPRESENTATIVE REPORTED THE PATIENT HAD EXPERIENCED SYMPTOMS OF REDNESS AND SCABBING AT THE INS IMPLANT SITE. THE PATIENT HAD DEVELOPED AN INFECTION; THE CAUSATIVE ORGANISM WAS UNKNOWN. THE PRODUCT WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE PATIENT WAS RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.
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 | 45 YR | Required Intervention | STIM ACCESSORY PLUG MODEL UNK LOT# UNK| EXPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD054941N| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3778 LOT# UNK |