BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL FSR

    MDR report key: 3797947 · Received May 7, 2014

    Report

    Report Number
    2017865-2014-13512
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    February 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND AN INSULATION ABRASION AT 47.7 CM TO 48.0 CM FROM CONNECTOR PIN WHICH EXPOSED THE OUTER COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVISION OF THE RIGHT VENTRICULAR LEAD, BODY FLUIDS WERE NOTED IN THE LEFT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274264 TENDRIL FSR PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1699TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1