BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3924247 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15154
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM IN A SYNCOPAL STATE. MULTIPLE INSTANCES OF NOISE ON THE RIGHT VENTRICULAR LEAD HAD CAUSED AN INHIBITION OF THERAPY. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400533 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1488TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention