BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2905280 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00651
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 7, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 8.0 CM TO 8.3 CM FROM THE CONNECTOR PIN, EXPOSING THE OUTER COIL, DUE TO FRICTION WITH THE DEVICE CAN.

    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 EXHIBITED LOSS OF SENSING. THE DEVICE WAS EXPLANTED DURING AN UNRELATED PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10927 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR