BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR VENTRICULAR ENDOCARDIAL LEAD

    MDR report key: 3925921 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15315
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 16, 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
    FL, 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

    NEW INFORMATION NOTES: THE LEAD WAS CAPPED DUE TO HIGH THRESHOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403147 BIPOLAR VENTRICULAR ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1216T/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention