FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1951965
·
Received January 4, 2011
Report
- Report Number
- 3004209178-2011-00044
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- January 1, 2009
- Report Date
- December 17, 2010
- 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
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WENT THROUGH AIRPORT SECURITY WHICH DRAINED THE IMPLANTABLE NEUROSTIMULATOR BATTERY. SHE WAS ABLE TO RECHARGE HER DEVICE AFTERWARD. 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 RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | EXTENSION: MODEL 37082, LOT# NKB003350N| ACCESSORY: MODEL 37752, LOT# NKA021398N| PROGRAMMER: MODEL 37742, LOT# NJD029135N| EXPLANTED:| LEAD: MODEL 3999, LOT# V010129| EXPLANTED:| IMPLANTED:| IMPLANTED: |