BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3925748 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15624
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 6, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.FINAL ANALYSIS FOUND DAMAGE TO THE INNER INSULATION OF THE LEAD AT 16.6 TO 16.8CM FROM THE CONNECTOR PIN. THIS DAMAGE COULD HAVE CONTRIBUTED TO THE OVERSENSING OBSERVED ON THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS OBSERVED ON THE ATRIAL LEAD. DUE TO THE IMPLANT TECHNIQUE AND THE PATIENTS ACTIVITY LEVELS, LEAD DAMAGE DUE TO CLAVICULAR CRUSH WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404349 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention