SOLETRA
Report
- Report Number
- 3004209178-2013-01097
- Event Type
- Injury
- Date Received
- January 30, 2013
- Report Date
- January 16, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387-40 LOT# J0519173V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387-40 LOT# J0519173V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE 'WERE NO LEAD FRACTURES TO THE REPORTER'S KNOWLEDGE.'
IT WAS REPORTED THAT LOW IMPEDANCES (9 OHMS) ON ELECTRODE COMBINATION OF #0 AND 1 ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATORS (INS). IT WAS UNCLEAR WHICH INS SYSTEM HAD THE LOW IMPEDANCE. IT WAS NOTED THAT THE PATIENT WAS GETTING THERAPEUTIC RELIEF EVEN WITH THE LOW IMPEDANCE ISSUE. BOTH OF THE PATIENT'S INSS WERE REPLACED DUE TO "LONGEVITY REASONS". FOLLOWING THE INS BATTERY REPLACEMENT THE PATIENT WAS GETTING THERAPEUTIC RELIEF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT #3004209178-2013-01096.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40460 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |