BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2983889 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01496
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEFIBRILLATOR CHANGE OUT, THE LEAD INSULATION EXHIBITED AN ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88590 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR