FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1222422
·
Received November 5, 2008
Report
- Report Number
- 3004209178-2008-07224
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- June 1, 2008
- Report Date
- October 11, 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
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STIMULATOR WOULD TURN OFF FOR 1-2 MINUTES APPROXIMATELY 4 TIMES A DAY, THOUGH THE STIMULATOR WOULD INDICATE IT WAS TURNED ON. THE PATIENT ALSO NOTED LACK OF EFFECT WITH INCREASED PAIN AND NO STIMULATION SENSATION. REVIEW OF THE PUMP (2008) REVEALED HIGH IMPEDANCES ON MULTIPLE ELECTRODES. THE PATIENT UNDERWENT SURGERY TO REPLACE BOTH LEADS. FOLLOWING SURGERY THE PATIENT'S PAIN WAS IMPROVING. THE PATIENT RECOVERED WITHOUT SEQUELA.
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 | IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 37743 LOT# NKE103658N| RECHARGER MODEL 37752 LOT# NKA110028N| EXPLANTED:| LEAD MODEL 3777 LOT# V082515036| LEAD MODEL 3777 LOT# V082515038 |