FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2160647
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05176
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- December 23, 2010
- Report Date
- June 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WENT IN FOR A PADDLE LEAD REVISION AND THE PHYSICIAN ENDED UP EXPLANTING HER NEUROSTIMULATION SYSTEM. THE PT STATED "A FEW PIECES OF LEAD REMAINED IN HER SPINE." ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | ACCESSORY: MODEL 37752, LOT# NKA012437N| LEAD: MODEL 3998, LOT# L94212| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001154N| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD012030N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001177N |