BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3926218 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15539
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 22, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND INSULATION ABRASION EXPOSING THE OUTER COIL AT 49.4 CM TO 50.3 CM AND 50.8 CM TO 51.3 CM FROM THE CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH THAT OF EXPOSURE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404671 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention