BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEC, BI, EPICARDIAL

    MDR report key: 3925547 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08635
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    February 4, 2013
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH PUT OF RANGE IMPEDANCE AND HIGH CAPTURE THRESHOLD WERE NOTED. THE LEAD WAS SUSPECTED TO HAD BEEN CUT OR DAMAGED DURING IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO CAP AND REPLACE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38373 BIOMEC, BI, EPICARDIAL PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention