BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1955767 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00700
    Event Type
    Injury
    Date Received
    January 10, 2011
    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 Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS DISLODGED AND WERE UNABLE TO BE REPOSITIONED. THE LEADS WERE 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 1488T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention (B)(4)