FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1151328
·
Received September 4, 2008
Report
- Report Number
- 3004209178-2008-05446
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 5, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS HAVING PROBLEMS WITH RECHARGING DUE TO PROBLEMS WITH COUPLING; THE PATIENT WAS UNABLE TO GET EFFICIENCY BARS. TWO DAYS LATER, ANTENNA LOCATOR WAS PERFORMED. THEY WERE ABLE TO GET 56 AFTER MOVING TO SEVERAL DIFFERENT LOCATIONS. IT WAS DETERMINED THAT THE NEUROSTIMULATOR HAD BEEN IMPLANTED TOO DEEP BASED ON ANTENNA LOCATOR. THE POCKET WAS REVISED. AFTER THE REVISION, "ALL IS FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL 3998 LOT# V110881| EXTENSION MODEL 37082 LOT# NKB012901N| PROGRAMMER MODEL 37743 LOT# NKE112588N| ACCESSORY MODEL 37752 LOT# NKA116013N| EXPLANTED| EXPLANTED |