BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3923414 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14705
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 3, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS DAMAGED AT 17 CM TO 18 CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH. THE COIL WAS FRACTURED AT THE SAME LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP, THE RIGHT VENTRICLE LEAD EXHIBITED NOISE CAUSING PACING INHIBITION; IT ALSO EXHIBITED LOW IMPEDANCES. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400523 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention