RESTORE
Report
- Report Number
- 3004209178-2011-10118
- Event Type
- Injury
- Date Received
- December 29, 2011
- Report Date
- December 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
REPORTABLE INFORMATION WAS RECEIVED (B)(6) 2011.
LEAD MODEL 377775 LOT# V003642 IMPLANTED: (B)(6) 2006 EXPLANTED: (B)(6) 2011; LEAD MODEL 377775 LOT# V004479 IMPLANTED: (B)(6) 2006 EXPLANTED: (B)(6) 2011; PROGRAMMER MODEL 37742 SERIAL# (B)(4).
ADDITIONAL INFORMATION. PRIOR TO THE REPLACEMENT THE PATIENT COULD FEEL STIMULATION "SLIGHTLY" AT "VERY" HIGH SETTINGS. BECAUSE THE DEVICE HAD BEEN IN AN OVERDISCHARGED STATE FOR OVER A YEAR THE PATIENT WAS NOT SURE WHEN STIMULATION WAS LAST CONSIDERED "GOOD," SO IT WAS UNCLEAR IF THE PATIENT'S RADIATION TREATMENT WAS RELATED TO THE EVENT. IT WAS ALSO NOTED THERE WERE HIGH IMPEDANCES ON THE EXISTING LEADS.
IT WAS REPORTED THAT THE PATIENT HAD BEEN IN A STATE OF OVERDISCHARGE FOR OVER A YEAR. THE PATIENT HAD NOT CHARGED HER DEVICE DUE TO HEALTH ISSUES, AS SHE HAD TO GO THROUGH RADIATION AND CHEMOTHERAPY. WHEN THE PATIENT TRIED TO CHARGE HER DEVICE, SHE WAS UNSUCCESSFUL. REPROGRAMMING OF THE PATIENTS IMPLANTABLE NEUROSTIMULATOR (INS) WAS DID NOT RESOLVE THE ISSUE. THE PATIENT'S INS AND LEADS WERE REPLACED ON (B)(6) 2011. NO INFORMATION RELATING THE PATIENT OUTCOME WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION. THE PATIENT WAS DOING "WELL" WITH "GOOD" PAIN COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |