BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4191994 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04625
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION: EXAMINATION OF THE LEAD REVEALED INSULATION WAS CUT ADN COIL WAS BENT. INNER INSULATION WAS CUT/DAMAGED AT 23.9 CM AND 25.6 CM FROM CONNECTOR PIN. THE DAMAGES FOUND ON THE LEAD ARE CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED INTERMITTENT CAPTURE DURING IMPLANT. THE LEAD AND PULSE GENERATOR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29805 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PM2210, 7138721