SOLETRA
Report
- Report Number
- 3004209178-2013-07017
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 17, 2013
- 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
- KS, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389-40, LOT# J0206490V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0206490V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THE PATIENT HAD A LOW BATTERY WARNING. THE BATTERY LONGEVITY WAS REQUESTED FOR A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). LONGEVITY CALCULATION WAS 2 YEARS FOR THIS BATTERY WHICH WAS AT 4.9 VOLTS. IT WAS NOTED THIS BATTERY WILL BE REPLACED. LONGEVITY CALCULATION FOR THE OTHER BATTERY WAS 4.3 YEARS AND WILL NOT BE REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185572 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |