BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2983785 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01500
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 14, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 7.2 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH DEVICE CAN. THE PROXIMAL INSULATION WAS DAMAGED AT MULTIPLE POSITIONS DUE TO ELECTROCAUTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INSULATION EXHIBITED AN ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88554 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention