FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1872579
·
Received October 12, 2010
Report
- Report Number
- 3004209178-2010-07846
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 14, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PT HAD NO STIMULATION SENSATION, FOLLOWING A POSITION CHANGE. THE PT WAS HOME. PT WAS LOOKING FOR A PROVIDER AND WILL HAVE HIS DEVICE CHECKED. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB002169V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 377745, LOT# V007298| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD021813N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA017726N| EXPLANTED: |