FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2873525
·
Received December 14, 2012
Report
- Report Number
- 3007566237-2012-03015
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Report Date
- November 21, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- 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
CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 7482, PRODUCT TYPE: EXTENSION . (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REPLACED ON (B)(6) 2012. THE NEXT DAY, THE HEALTHCARE PROVIDER (HCP) NOTICED THAT THE INSULATION OF THE EXTENSION SEEMED MELTED AGAIN. IT WAS NOTED THAT IT SEEMED LIKE IT "BROKE ONLY THE SURFACE". THE HCP DECIDED TO KEEP USING IT AS THERE WAS NO PROBLEM RELATED TO THE CONDITION. THE HCP UNDERSTOOD THAT THE MATERIAL USED FOR THE PRODUCT WAS SUITABLE FOR IMPLANT, EVEN THOUGH IT HAPPENED AGAIN. THE HCP SUSPECTED THAT THE MATERIAL MAY HAVE DETERIORATED. PLEASE SEE MANUFACTURING REPORTS #9614453-2012-00036 AND #9614453-2012-00037 FOR RELATED EVENT. THE PREVIOUS MELTED EXTENSION WAS MENTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |