FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 1181387
·
Received September 24, 2008
Report
- Report Number
- 3004209178-2008-06110
- Event Type
- Injury
- Date Received
- September 24, 2008
- Date of Event
- August 29, 2008
- Report Date
- May 6, 2021
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT EXPERIENCED INTERMITTENT STIMULATION WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON. THE DEVICE MOVED AROUND IN THE POCKET AND STIMULATION WOULD TURN ON WHEN IT WAS PRESSED UPON. IMPEDANCES WERE GREATER THAN 3600 OHMS ON SOME OF THE ELECTRODES WHEN TESTED AT AN AMPLITUDE OF 0.4-0.5 VOLTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WIL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention | IMPLANTED:| EXTENSION: MODEL 37083| PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3986A| ACCESSORY: MODEL 37752| EXPLANTED:| EXPLANTED:| EXPLANTED: |