BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2170258 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09854
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTING INAPPROPRIATE SHOCK DID NOT CAUSE AN EXHAUSTION OF RESCUE THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID PROVIDE INAPPROPRIATE SHOCK THERAPY. DEVICE PROGRAMMING HAD BEEN SET-UP AS THREE ZONES WITH VT-1 AT 150 MONITOR ONLY, 180 VT, AND VF OF 210. THIS PATIENT HAS HAD A HISTORY OF CROSSING OVER FROM VT-1 SINUST/ATRIAL TACHY. THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP), THEN 1.1 JOULES SHOCK WHICH TRIGGERED ATRIAL FLUTTER, AFTER WHICH THE PATIENT THEN RECEIVED THREE MORE 41 JOULES SHOCKS. THE FIRST SHOCK DID CONVERT THE ATRIAL FLUTTER, AND THE OTHER TWO WERE FOR THE ATRIAL DRIVEN RHYTHM. THE PATIENT WAS NOTED TO HAVE REMAINED CONSCIOUS DURING ALL THE EVENTS. THE FOLLOWING PHYSICIAN ELECTED TO RE-PROGRAM THE DEVICE BY TAKING OUT THE MONITOR ONLY ZONE AND DOUBLING THE DURATION OF THE VT AND VF ZONES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR 0184| E110| 4054