BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911301 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16017
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    October 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS RECENTLY SEEN AT THE EMERGENCY ROOM AFTER RECEIVING TWO SHOCKS FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) WAS CALLED TO INTERROGATE THE DEVICE. THE DEVICE WAS FOUND TO HAVE DETECTED AN ARRHYTHMIA IN THE MONITOR ONLY VT-1 ZONE, AND INHIBITED APPROPRIATELY, HOWEVER, WHEN THE RHYTHM ACCELERATED INTO THE VT ZONE, THERE WAS MULTIPLE ROUNDS OF ATP DELIVERED THAT NEVER CONVERTED THE ARRHYTHMIA. THIS WAS THEN FOLLOWED BY TWO SHOCKS, WHICH ALSO DIDN'T CONVERT THE ARRHYTHMIA, HOWEVER THE PATIENT SELF TERMINATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THE DEVICE WAS OPERATING APPROPRIATELY BASED ON PROGRAMMED PARAMETERS. THE DEVICE REMAINS IN SERVICE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS LATER, THE PHYSICIAN CONTACTED OUR BOSTON SCIENTIFIC FIELD REPRESENTATIVE TO REQUEST ADDITIONAL DEVICE DATA FROM TWO EVENTS IN WHICH THE PATIENT RECEIVED SHOCKS BACK IN (B)(6) 2012. THE FIRST EVENT OCCURRED ON (B)(6) AND THE SECOND ON (B)(6) . THERE WERE SOME QUESTIONS ABOUT DEVICE PROGRAMMING AND CONCERN THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. AFTER FURTHER REVIEW OF DEVICE DATA, IT WAS BELIEVED THAT THE SHOCKS WERE APPROPRIATE FOR TRUE VT. THE FIELD REPRESENTATIVE CONFIRMED THERE WERE NO ADVERSE PATIENT EFFECTS, BUT DID NOTE THE PATIENT SUFFERED SOME PSYCHOLOGICAL STRESS OVER THE CONCERN OF RECEIVING INAPPROPRIATE SHOCKS FROM THEIR DEVICE. THE FIELD REPRESENTATIVE CONFIRMED THERE HAVE BEEN NO FURTHER ISSUES REPORTED RELATING TO DEVICE PERFORMANCE IN THEIR TERRITORY. THE REASON THIS EVENT WAS REOPENED WAS BECAUSE THE PHYSICIAN WAS REQUESTING ADDITIONAL DEVICE DATA AS THEIR CLINIC IS UNDER LITIGATION WITH THE PATIENT. AT THIS TIME, BOSTON SCIENTIFIC HAS NOT RECEIVED ANY FORMAL COMPLAINTS RELATED TO LEGAL ACTION AGAINST THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18001 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 0185| E102