FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2133556
·
Received June 15, 2011
Report
- Report Number
- 3004209178-2011-04463
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 19, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT'S STIMULATION WAS NOT ON. THE PATIENT'S PROGRAMMER WAS LOST IN A FIRE SO THE PATIENT WAS USING THE RECHARGER TO TURN THE DEVICE ON AND OFF. AN OVERDISCHARGE WAS SUSPECTED AS THE PATIENT EXPERIENCED RECHARGE COUPLING DIFFICULTIES. THE HEALTHCARE PROVIDER (HCP) SAW AN END OF SERVICE/END OF LIFE (EOS / EOL). TROUBLESHOOTING WAS PERFORMED, BUT THE HCP WAS UNABLE TO READ, RECHARGE, OR PROGRAM THE DEVICE. THE DEVICE WAS REPLACED.
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 | 71 YR | Required Intervention | LEAD: MODEL 3778, LOT# V002518| PROGRAMMER: MODEL 37742, LOT# NJD016575N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V001853| IMPLANTED:| IMPLANTED: |