BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3924180 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15102
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND EXCESSIVE MEDICAL ADHESIVE ON THE RING ELECTRODE. THIS COULD HAVE CONTRIBUTED TO THE REPORTED ELECTRICAL ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CAPTURE COULD NOT BE ACHIEVED DURING IMPLANT OF ATRIAL LEAD. HIGH IMPEDANCE WAS OBSERVED AND A FRACTURE WAS SUSPECTED. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400386 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR