FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 2090846
·
Received April 26, 2011
Report
- Report Number
- 3004209178-2011-03102
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Report Date
- April 7, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION AND AN OVERSTIMULATION SENSATION. THE SYMPTOMS OCCURRED FOLLOWING THE INSTALLATION OF A "SMART MONITOR" IN THE PT'S HOME IN ORDER TO MONITOR ELECTRICITY USAGE. THE STIMULATOR HAD BEEN REPROGRAMMED A "FEW" TIMES, AND THE STIMULATION WAS BETTER WHEN THE PT WAS AWAY FROM HOME. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 | EXPLANTED:| LEAD: MODEL 3776, LOT# V186008033| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776, LOT# V186008031| IMPLANTED: |