ACTIVA
Report
- Report Number
- 3004209178-2013-04543
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Report Date
- September 5, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 3389S-40 LOT# V877540, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-40 LOT# V877540, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
IT WAS REPORTED, THE PATIENT WAS FLIPPING THEIR STIMULATOR IN THEIR POCKET. IT WAS ALSO NOTED, THE PATIENT HAD TINGLING IN THEIR FOREHEAD. IT WAS REPORTED, THE DEVICE WAS CHECKED AND ALL CONTACTS WERE FINE ON BOTH SIDES. FOLLOW UP REPORTED A LEAD CONNECTION CHECK WAS PERFORMED AND ALL CONTACTS WERE FUNCTIONING PROPERLY. THE CAUSE OF THE TINGLING WAS NOT DETERMINED AND DID NOT RESOLVE. THERE WERE NO INTERVENTIONS PLANNED OR TAKEN AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED HURTING IN THE HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136080 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |