FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1926280
·
Received November 11, 2010
Report
- Report Number
- 3004209178-2010-09335
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 26, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RECHARGER DID NOT APPEAR TO BE FUNCTIONING APPROPRIATELY. THE COUPLING EFFICIENCY WAS POOR SINCE THE PT FELL ABOUT 6 WEEKS AGO. THE RECHARGER SHOWED 10% WHILE THE INS FLASHED BETWEEN 25% AND 50%. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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 | 72 YR | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA141306N| IMPLANTED:| LEAD: MODEL 3778, LOT # V464273031| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT # N250558| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE149411N| EXPLANTED: |