BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1223484 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03224
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND BOTH THE PROXIMAL AND DISTAL INSULATIONS DAMAGED AT 23 CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DEFECTIVE.

    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 1488TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention