FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2915415
·
Received January 15, 2013
Report
- Report Number
- 3004209178-2013-00584
- Event Type
- Malfunction
- Date Received
- January 15, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 19, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V040724, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V059842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WENT TO (B)(6) LIBRARY THREE DAYS PRIOR AND WENT THROUGH GATES THAT TURNED THE PATIENT'S STIMULATION OFF. IT WAS NOTED THE PATIENT USED THEIR PATIENT PROGRAMMER TO TURN THE DEVICE BACK ON AND THE DEVICE HAD BEEN WORKING SINCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22141 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR |