FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1941189
·
Received December 22, 2010
Report
- Report Number
- 3004209178-2010-10698
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Report Date
- December 12, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE END OF SERVICE MESSAGE DISPLAYED POST A PHYSICIAN MODE RECHARGE. THERE WERE TELEMETRY ISSUES AND THE DEVICE MAY BE OVERDISCHARGED FOR THE THIRD TIME. THE COMPANY REPRESENTATIVE CONFIRMED THAT THE NEUROSTIMULATOR (INS) WOULD NOT TRICKLE CHARGE. THE PT HAD A FALL AFTER THE DEPLETION OF THE INS. AN X-RAY SHOWED THAT THE LEADS HAD MIGRATED FROM T7 TO T12. THE PT WAS REFERRED TO A NEUROSURGEON.
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 | LEAD: MODEL 3777, LOT# V008319| LEAD: MODEL 3778, LOT# V295361027| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA035625N| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: |