FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1193440
·
Received October 7, 2008
Report
- Report Number
- 3004209178-2008-06404
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE HCP "DISCOVERED" THAT PATIENT'S LEAD HAD MIGRATED AGAIN POSSIBLY DUE TO SEIZURES. NO SPECIFIC TESTS WERE REPORTED. THE HCP RECOMMENDED A LEAD REVISION USING A PADDLE LEAD TO MAKE THE LEAD MORE SECURE. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | LEAD: MODEL 3778| EXPLANTED: |