BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK C

    MDR report key: 1043146 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33495
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0064 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE 0010/008209 WAS IMPLANTED 28-MAR-1994| THE DEVICE 6836/008115 WAS IMPLANTED 08-APR-1994| THE DEVICE 1857/704944 WAS IMPLANTED 04-JAN-2008| THE DEVICE 0063/004485 WAS IMPLANTED 08-APR-1994