FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 3245415
·
Received July 24, 2013
Report
- Report Number
- 3007566237-2013-02469
- Event Type
- Injury
- Date Received
- July 24, 2013
- Report Date
- April 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER IMPLANT THE PATIENT HAD TINNITUS, FELT ¿PALPITATE,¿ AND TIGHTNESS IN THE CHEST. THE PATIENT WAS A DJ AND WONDERED WHETHER THE DJ DEVICE INFLUENCED THE IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346439 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00031 YR | Other |