BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 2014009 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01453
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 13, 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 Location
    AZ
    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 PROXIMAL INSULATION WAS ABRADED AT 7 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED. MULTIPLE ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. SUBSEQUENTLY THE LEAD WAS REPLACED.

    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 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4)