FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1200057
·
Received October 15, 2008
Report
- Report Number
- 3004209178-2008-06566
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 18, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATOR WAS TURNING ON AND OFF WHEN THE PT WAS CLOSE TO OR USED HIS CELL PHONE. NO PT SYMPTOMS WERE REPORTED. THE PT WAS AT HOME AT THE TIME OF THE REPORT. HIS STATUS WAS REPORTED AS GOOD. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 | 53 YR | EXPLANTED:| DEEP BRAIN STIMULATOR SYSTEM: MODEL # 7426| LEAD: MODEL 3387| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A| IMPLANTED: |