BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3924021 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14962
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 14, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE INSULATION ADJACENT TO THE SMALL SEALING RINGS WAS MEASURED OUT OF SPECIFICATION. THE CONNECTOR BOOT WAS ALSO MEASURED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE ATRIAL LEAD INTO THE HEADER OF THE PULSE GENERATOR, THE LEAD PIN COULD NOT BE INSERTED PAST THE SETSCREW. THE LEAD WAS NOT USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399348 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR