FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1250376
·
Received December 3, 2008
Report
- Report Number
- 3004209178-2008-07964
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- November 1, 2008
- Report Date
- November 6, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT BEGAN RECHARGING HER IMPLANTABLE NEUROSTIMULATOR AT 8 AM AND STOPPED RECHARGING IN THE LATE AFTERNOON. THE PATIENT FELT A BURNING SENSATION ON HER SKIN. THE SKIN 'RIPPED OFF' WHEN HER HUSBAND REMOVED THE RECHARGER ANTENNA. PLEASE SEE MFR. REPORT # 3004209178200807961. THE PATIENT WAS SEEN BY HER HCP THE NEXT DAY. THE NEUROSTIMULATOR SITE WAS INFECTED AND HAD BEEN INFECTED FOR A COUPLE OF DAYS. NO OTHER PATIENT SYMPTOMS OR TREATMENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | PROGARMMER: MODEL 37743| LEAD: MODEL 3777| EXPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777| IMPLANTED: |