BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3924174 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15096
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INNER INSULATION WAS ABRADED AT 14.0 CM TO 14.4 CM FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE. THIS DAMAGE LIKELY CONTRIBUTED TO THE REPORTED NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD. A NOISE EPISODE HAD BEEN NOTED THE PREVIOUS YEAR. THE PATIENT WAS ASYMPTOMATIC. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399919 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 1688TC/46, DM111515