BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3926018 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15382
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT THE INSULATION ADJACENT TO THE SMALL SEALING RINGS WAS MEASURED TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD COULD NOT BE INSERTED INTO THE ATRIAL PORT OF THE PULSE GENERATOR EVEN WITH THE USE OF SILICONE OIL. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402731 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR