FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1061805
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03231
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Report Date
- May 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A JOLTING SENSATION WHILE REACHING UNDER THE HOOD OF THE CAR. THE STIMULATION WORKS BUT THE PATIENT HAS FELT TIRED AND EXPERIENCED CONSTIPATION. AT THE TIME OF THE REPORT THE PATIENT WAS AT THE CLINIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL 3999| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 37082 |