BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 1893204 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08757
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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 PATIENT'S DEVICE WAS SHOWING HIGH IMPEDANCE READINGS. IT WAS STATED IMPEDANCES OF >4,000 OHMS WERE FOUND ON THE PATIENT'S DEVICE. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS LATER STATED THE PATIENT WAS FOUND TO HAVE A FRACTURED LEAD, WHICH WOULD REQUIRE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR LEAD: MODEL 3389, LOT# J0216972V| EXTENSION: MODEL 37085, LOT# NKN007743V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008583V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NFW143728H| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NGK017186N| ACCESSORY: MODEL 37651, LOT# NKA140581N| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| LEAD: MODEL 3389, LOT# J0220046V