BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2240182 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05613
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 6, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 7 CM TO 7.5 CM FROM THE CONNECTOR PIN AND EXPOSED THE COIL. ABRASIONS ARE INDICATIVE OF EXPOSURE TO CONSTANT FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOW IMPEDANCE AND DECREASED SENSING. 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 1788T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7120/58, (B)(4)