FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1202084
·
Received October 16, 2008
Report
- Report Number
- 3004209178-2008-06597
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- September 14, 2008
- Report Date
- September 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERAITONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A SHOCK WHILE WALKING PAST A STORE THEFT DETECTOR WITH HER IMPLANTABLE NEUROSTIMULATOR ON. THE PATIENT STOPPED FEELING STIMULATION AFTERWARDS. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE DEVICE. THE PATIENT WAS SEEN BY HER HCP 5 DAYS LATER. SHE CHARGED HER NEUROSTIMULATOR FOR 8-9 HOURS AFTER THE CLINIC VISIT. WHEN SHE TRIED TO USE THE DEVICE, IT WAS IN A POWER ON RESET CONDITION; A 'CALL YOUR DOCTOR' ICON WAS DISPLAYED ON THE PATIENT PROGRAMMER. THE PATIENT WAS SEEN BY A FIELD REPRESENTATIVE, WHO CLEARED THE POWER ON RESET CONDITION. THE PATIENT WAS ABLE TO RECHARGE COMPLETELY AND RESUME THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERAITONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | LEAD: MODEL 3777| PROGRAMMER: MODEL 37742| LEAD: MODEL 3777| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| IMPLANTED: |