BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4987916 · Received August 10, 2015

    Report

    Report Number
    3004209178-2015-15656
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Report Date
    July 14, 2015
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64001, LOT# N242051, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37092, LOT# 279260001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387-40, LOT# J0309618V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE THAT REPORTED THE PATIENT WOULD TYPICALLY TURN THE DEEP BRAIN STIMULATOR (DBS) ON AND OFF ACCORDING TO THEIR NEEDS DURING THE WEEK. WHEN HE TURNED THE SYSTEM ON, HE WOULD KNOW IT WAS ON BECAUSE HE FELT A SHOCK OR VOLTAGE SENSATION IN HIS RIGHT CHEEK. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THE STIMULATION IN HIS RIGHT CHEEK WHEN THE THERAPY WAS TURNED ON WAS NORMAL AND IT WAS ONLY TEMPORARY. THE PATIENT WAS IMPLANTED FOR ESSENTIAL TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522130 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR