FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1181389
·
Received September 24, 2008
Report
- Report Number
- 3004209178-2008-06106
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 28, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT EXPERIENCED A SUDDEN LOSS OF THERAPY COINCIDING WITH A LOSS OF TELEMETRY. THE DEEP BRAIN STIMULATOR WAS NOT FLIPPED. THE PATIENT WAS SCHEDULED TO SEE A NEUROSURGEON FOR ASSESSMENT OF THE DEVICE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORTED WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT# 3004209178-2008-06105.
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 | 75 YR | NFW142797H| PROGRAMMER: MODEL 7438| EXTENSION: MODEL 7482| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| LEAD: MODEL 3387 |