BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 1042411 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34226
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1144/1145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 0185/190996 WAS IMPLANTED 05-MAR-2008| THE DEVICE T165/139241 WAS IMPLANTED 05-MAR-2008| THE DEVICE 1861/225052 WAS IMPLANTED 09-APR-2002| THE DEVICE 4086/104174 WAS IMPLANTED 09-APR-2002