BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2905117 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00763
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 18, 2012
    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. ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ATTEMPT TO IMPLANT THE VENTRICULAR LEAD THE PATIENT'S BLOOD PRESSURE DROPPED AND LOST CONSCIOUSNESS. CARDIAC PERFORATION WAS REVEALED. THE PATIENT RECEIVED A CARDIAC MASSAGE AND WAS PROVIDED OXYGEN. A TEMPORARY PACING LEAD WAS INSERTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11845 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention