BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 1896630 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05243
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD DISLODGED ONE DAY POST IMPLANT; THE LEAD WAS REPOSITIONED ON (B)(6) 2010. AT FOLLOW-UP ON (B)(6) 2010, LOSS OF CAPTURE WAS NOTED. THE LEAD WAS EXPLANTED AND REPLACED DUE TO CLAVICULAR CRUSH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/58 NA

    Patients

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