BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2609790 · Received June 11, 2012

    Report

    Report Number
    3004209178-2012-04300
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 14, 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
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 64002, LOT# N211753, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ADAPTER: PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYP: RECHARGER: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3389-40, LOT# J0437510V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 3389-40, LOT# J0421661V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND "TERRIBLE" PAIN. THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT PROGRAMMER SHOWED "CALL YOUR DOCTOR ICON" (POWER ON RESET (POR)). THE POR WAS CLEARED AND THE PATIENT WAS ABLE TO "TURN THERAPY BACK ON." THE DEVICE WAS CHARGED EVERY OTHER DAY. THE PATIENT DID NOT HAVE ANY MEDICAL TESTS. 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
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR