BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2081495 · Received April 20, 2011

    Report

    Report Number
    3004209178-2011-02961
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS UNABLE TO ADJUST THE STIMULATION. THE DISPLAY SHOWED "CALL YOUR DOCTOR" ICON AND A POWER ON RESET (POR) CONDITION. THE HEALTHCARE PROVIDER (HCP) RECEIVED A CALL FROM THE PT ON SUNDAY THAT REPORTED THE DEVICE WAS "RESET." THE HCP REVIEWED HOW TO CLEAR MESSAGE WITH THE PT. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT # NKN009059V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT # V443426| EXTENSION: MODEL 37085, LOT # NKN009060V| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT # 250430002| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT # V476627