ACTIVA
Report
- Report Number
- 3004209178-2013-03410
- Event Type
- Injury
- Date Received
- March 6, 2013
- Report Date
- February 13, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3387S-40 LOT# V373400, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).
CONCOMITANT PRODUCT: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V012262, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; CONCOMITANT SYSTEM: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V373400, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).
IT WAS REPORTED THAT THE PATIENT DEVELOPED CANCER IN HIS CAROTID GLAND AND HAD TO HAVE HIS IMPLANTABLE NEUROSTIMULATOR (INS) MOVED DOWN TO HIS ABDOMEN. IT WAS STATED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THAT AN ESTIMATED REPLACEMENT INDICATOR AND END OF SERVICE INDICATOR SHOW ON PATIENT PROGRAMMER. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95756 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |