BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2976147 · Received February 25, 2013

    Report

    Report Number
    3004209178-2013-03004
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V236136, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A PATIENT WAS SWITCHING SETTINGS, A POR (POWER ON RESET) CONDITION WAS SEEN. THE PATIENT WAS NOT ABLE TO ADJUST SETTINGS. 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
    79742 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1