BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 684371 · Received February 9, 2001

    Report

    Report Number
    2124215-2001-02496
    Event Type
    Malfunction
    Date Received
    February 9, 2001
    Date of Event
    April 9, 1999
    Report Date
    October 6, 2000
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD HAD DISLODGED AND WAS REPOSITONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5210 ENDOTAK DSP TRANSVENOUS DEFIBRILLATION LEAD LWS CARDIAC PACEMAKERS 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other