BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1955752 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00955
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 3, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 21.0 CM TO 21.2 CM FROM THE CONNECTOR PIN. ABRASIONS ARE INDICATIVE OF EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED NOISE. THE NOISE WAS REPRODUCIBLE IN CLINIC AND WAS PAROXYSMAL IN NATURE. IT WAS SUSPECTED THAT THE NOISE WAS CAUSED BY THE LEADS RUBBING AGAINST EACH OTHER AND CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention (B)(4)