BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1771649 · Received July 28, 2010

    Report

    Report Number
    2124215-2010-12105
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    May 17, 2010
    Report Date
    October 19, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION OF THE LEAD BARRELS AND DEVICE HEADER NOTED NO IRREGULARITIES. THE BATTERY STATUS WAS ELECTIVE REPLACEMENT INDICATOR (ERI). THE ALLEGED INAPPROPRIATE SHOCK EPISODES HAVE SINCE BEEN OVERWRITTEN DUE TO THE LENGTH OF TIME FROM ALLEGATION TO ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE. THE ATP ACCELERATED THE PATIENT'S VT AND AN INAPPROPRIATE SHOCK WAS DELIVERED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED FOR AN UNRELATED REASON AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4470| T167| E110| 0185