BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043553 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33101
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 2, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THE DEVICE 4517/418468 WAS IMPLANTED 15-JUN-2005| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4524/158236 WAS IMPLANTED 15-JUN-2005| THE DEVICE 0175/108771 WAS IMPLANTED 15-JUN-2005| THE DEVICE 4512/403763 WAS IMPLANTED 15-JUN-2005| THE DEVICE 6481 305919 WAS USED DURING THE EVENT.| THE DEVICE 4244/439482 WAS IMPLANTED 15-JUN-2005