FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1133121
·
Received August 22, 2008
Report
- Report Number
- 3004209178-2008-05175
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
AFTER THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. THE DEVICE WAS TURNING OFF. THE PATIENT WAS GETTING GREAT THERAPEUTIC EFFECT, BUT IT WAS A NUISANCE FOR HER TO TURN THE DEVICE BACK ON. IMPEDANCES WERE NORMAL. THE PATIENT WAS KEEPING A DIARY OF THE DEVICE TURNING OFF. 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 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LEAD: MODEL 3387| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387| LOT# NFW149891H| EXTENSION: MODEL 7482| EXPLANTED:| EXPLANTED: |