FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2120147
·
Received June 6, 2011
Report
- Report Number
- 3004209178-2011-03984
- Event Type
- Injury
- Date Received
- June 6, 2011
- Date of Event
- May 6, 2011
- Report Date
- May 6, 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
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S STIMULATION WAS TURNING OFF. THE PT WAS ADMITTED TO THE HOSPITAL ON MONDAY AND JUST REPORTED THIS MORNING THAT STIM IS OFF. THE PT DID NOT TURN STIM OFF. THE PT WAS RECHARGING INS. WHEN PT TURNS STIM ON, STIM TOO HIGH. THE PT DIDN'T HAVE PROGRAMMER WITH THEM SO THEY TURNED OFF USED INSR. ADDITIONAL INFO WAS REQUESTED.
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 | 35 YR | Hospitalization | EXTENSION: MODEL 7489, LOT# NHU087350V| PROGRAMMER: MODEL 37742, LOT# NJD022700N| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0436930V| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0421677V| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA018864N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000815N| EXPLANTED:| IMPLANTED: |