FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1053629
·
Received May 23, 2008
Report
- Report Number
- 3004209178-2008-02778
- Event Type
- Injury
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 23, 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 THAT THE INS SYSTEM WAS REMOVED DUE TO "STAPH" INFECTION. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | EXPLANTED:| EXPLANTED:| LEAD MODEL 3776 LOT# V009235 IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD034573N IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD MODEL 3776 LOT# V009387 IMPLANTED:| ACCESSORY MODEL 37752 LOT# NKA024164N IMPLANTED:| EXTENSION MODEL 37081 LOT# NJB006247V IMPLANTED: |