FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 3231875
·
Received July 17, 2013
Report
- Report Number
- 3007566237-2013-02378
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- 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 THE PATIENT HAD DIMINISHING BENEFIT. THERE WAS ¿SOME ANOMALIES¿ SEEN IN THE IMPEDANCE RESULTS. IT WAS NOTED THAT THE ACTIVATION WAS ¿0¿ AND THE ¿%¿ USED COULD NOT BE MEASURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331514 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |