FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 3083005
·
Received April 29, 2013
Report
- Report Number
- 3007566237-2013-01463
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 10, 2013
- 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).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A RELAPSE OF SYMPTOMS AT HOME AND SUSPECTED THE DEVICE POWERED DOWN. IT WAS CONFIRMED BY ACCESS REVIEW, WHEN THE PATIENT HAD RELAPSING SYMPTOMS THE DEVICE HAD BEEN POWERED DOWN SEVERAL TIMES. DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT NO TROUBLE SHOOTING HAS BEEN DONE YET. THE RETURN OF SYMPTOMS WERE CLARIFIED AS "MOVEMENT IS NOT GOOD." BY USING ACCESS REVIEW, THE PATIENT HAS RECEIVED EFFECTIVE THERAPY. NOTHING HAS BEEN PLANNED BUT THE PATIENT WAS GOING TO SEE THEIR PHYSICIAN ON (B)(6) TO DISCUSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185226 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |