BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896507 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04983
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 20, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    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

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 5.5 CM AND AT 21.5 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH ANOTHER DEVICE, WHICH COULD CAUSE THE NOISE PROBLEM.

    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 ATRIAL LEAD EXHIBITED NOISE DUE TO RIB CLAVICLE CRUSH OR AN INSULATION BREAK. FURTHER INVESTIGATION OF THE LEAD WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688T/58 NA

    Patients

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