BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 4231458 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18227
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 28, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND AN INSULATION ABRASION EXPOSING THE OUTER COIL AT 19.5 CM TO 19.7 CM FROM THE CONNECTOR PIN. ABRASIONS WAS CONSISTENT WITH CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. THIS COULD HAVE CAUSED THE REPORTED NOISE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. THE ATRIAL LEAD EXHIBITED MULTIPLE EPISODES OF NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713554 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 7171Q/65,BKT012456