FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1936132
·
Received December 13, 2010
Report
- Report Number
- 3007566237-2010-10376
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- January 1, 2009
- Report Date
- December 2, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S LEADS WERE REPLACED ON (B)(6) 2009. ON (B)(6) 2009, SHE VISITED THE CLINIC DUE TO A SENSITIVE GLUTEAL AREA, WHICH STARTED IN (B)(6) 2009. SHE HAD DEVELOPED AN INFECTION WITH NO FEVER OR CHILLS. THE CAUSE OF THE INFECTION AND IF IT WAS DEVICE RELATED WAS UNK. THE GLUTEAL AREA WAS ERYTHEMATOUS AND TENDER ON (B)(6) 2009. ANTIBIOTICS WERE ADMINISTERED FOR 2 WEEKS. ON (B)(6) 2009, THE DEVICE WAS EXPLANTED DUE TO THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD023924N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB015672N| EXPLANTED:| LEAD: MODEL 3998, LOT# V175498| ACCESSORY: MODEL 37752, LOT# NKA018008N| IMPLANTED: |