ACTIVA
Report
- Report Number
- 3004209178-2013-00861
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V606250, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V526048, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
IT WAS REPORTED THE PATIENT WAS TOLD BY THEIR HEALTHCARE PROVIDER (HCP) THAT THEIR BRAIN 'HAD DE-POWERED THEIR STIMULATOR' DURING AN APPOINTMENT IN SEPTEMBER. IT WAS ALSO STATED THAT THE HCP SAID THE PATIENT'S BRAIN HAD EITHER 'DE-POWERED OR RAISED THEIR SETTINGS ON ITS OWN' FROM THE LAST TIME IT WAS SET. IT WAS UNCLEAR WHAT CHANGES WERE ACTUALLY MADE TO THE STIMULATOR'S SETTINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A CT SCAN ON (B)(6) 2012, IN WHICH NO ABNORMALITY WAS SEEN AND THE LEADS WERE IN PLACE. IT WAS FURTHER STATED THAT THE PATIENT PERIODICALLY HAD 'FALLS' IN IMPEDANCE AND AN INCREASE IN CURRENT OUTFLOW. REPROGRAMMING REPORTEDLY CORRECTS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32386 | ACTIVA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |