FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1080255
·
Received July 22, 2008
Report
- Report Number
- 3004209178-2008-04248
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING AN UNRELATED MEDICAL PROCEDURE, THE PATIENT REPORTED NO STIMULATION SENSATION. IMPEDANCES WERE CHECKED AND IMPEDANCE ON ELECTRODES 3 & 4 WERE >4000. THE STIMULATOR WAS REPROGRAMMED ON THE REMAINING 2 ELECTRODES AND THIS PRODUCED SATISFACTORY STIMULATION FOR THE PATIENT IN THE AREA OF HER TYPICAL PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXTENSION MODEL 37083| ACCESSORY MODEL 37752| EXPLANTED| LEAD MODEL 3986A| EXPLANTED| PROGRAMMER MODEL 37742 |