BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 3924234 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15138
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS AND NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399922 ACTIVE FIXATION ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1188T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention