BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2240162 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05612
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 11, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    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. RELIABILITY LABORATORY TECHNICIAN, (B)(4). (B)(4) NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED FROM 18.1 CM TO 19.1 CM FROM THE CONNECTOR PIN. ABRASIONS ARE CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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