BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3231614 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11894
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    November 27, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V011075, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# V011075, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006: PRODUCT TYPE: EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 64002, LOT# N236358, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HAD DIED WITHOUT WARNING AS OF (B)(6) 2012. IT WAS NOTED THAT THE PATIENT WAS INFORMED BY HIS NEUROLOGIST THAT THERE WAS "PLENTY OF LIFE" IN THE BATTERY ON (B)(6) 2012. IT WAS NOTED THAT THE PATIENT "WILL HAVE TO HAVE ANOTHER IMPLANT AFTER ONLY 2.5 YEARS OF USE." THE PATIENT'S RIGHT SIDE TREMOR HAD RETURNED WITH "GREAT VIGOR." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331098 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1