ACTIVA
Report
- Report Number
- 3004209178-2012-10969
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Report Date
- November 2, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V374172, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT# J0227967V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEFT LEAD WAS FRACTURED WHICH WAS PERTAINED TO MANUFACTURER REPORT #3004209178-2012-10970.
IT WAS REPORTED THAT THE PATIENT WENT TO THEIR HEALTHCARE PROFESSIONAL ABOUT A MONTH AGO AND HAD X-RAYS OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) TAKEN WHICH SHOWED THAT 3 OUT OF THE 4 ELECTRODES WERE FRACTURED. IT WAS ALSO NOTED THAT THE PATIENT HAD REPROGRAMMING PERFORMED IN (B)(6) 2011. THE PATIENT HAD NOT DECIDED WHETHER TO HAVE A REVISION PERFORMED SINCE THE THERAPY WAS WORKING GREAT AND THEY WERE DOING WELL. IN ADDITION, THE PATIENT HAD REM SLEEP BEHAVIOR DISORDER (RBD) WHICH CAUSED NIGHTMARES WHICH SOMETIMES THEY ACTED OUT. ALSO, THE PATIENT WAS ON MEDICATIONS SO THEY DID NOT WAKE AND 'BEAT THINGS UP.' ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IN ADDITION, SEE MANUFACTURER'S REPORT #S 3004209178-2012-10967 AND 3004209178-2012-10968 FOR PREVIOUS ISSUES
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |