BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3923351 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14641
    Event Type
    Injury
    Date Received
    July 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. FINAL ANALYSIS FOUND AN INSULATION ABRASION AT 13 CM AND AT 54 CM FROM THE CONNECTOR PIN, WHICH EXPOSED THE OUTER COIL AT BOTH LOCATIONS. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED AN INSULATION ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401251 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention