SOLETRA
Report
- Report Number
- 3004209178-2013-10158
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- May 21, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7438, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT # V007376, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # V007376, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).
IT WAS REPORTED THE PATIENT¿S BATTERY ¿ONLY LASTED TWO YEARS AND ONE MONTH WHEN THEIR LAST BATTERY LASTED FOUR AND A HALF YEARS.¿ THE PATIENT HAS BILATERAL BATTERIES AND IT WAS UNCLEAR IF BOTH BATTERIES WERE DEPLETED. IT WAS UNKNOWN IF THE RIGHT SIDE WOULD BE REPLACED. REFERENCE MANUFACTURER REPORT # 3004209178-2013-10156. PATIENT HAD BILATERAL SYSTEMS AND IT WAS UNCLEAR WHETHER BOTH OR ONE SYSTEM HAD DEPLETED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOM OF SPASTICITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262709 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |