BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042292 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34359
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other THE DEVICE 6482 000959 WAS USED DURING THE EVENT.| THE DEVICE 6483 506010 WAS USED DURING THE EVENT.| THE DEVICE H217/700900 WAS IMPLANTED 06-JAN-2006| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6487 505120 WAS USED DURING THE EVENT.| THE DEVICE 4473/436402 WAS IMPLANTED 06-JAN-2006| THE DEVICE 4549/154821 WAS IMPLANTED 06-JAN-2006