BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212592 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09435
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 21, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A SUPRAVENTRICULAR TACHYCARDIA (SVT) FOR WHICH WAS INITIALLY DETERMINED TO BE CORRELATED VIA THE RHYTHM ID DEVICE FEATURE. THERAPY WAS DIVERTED HOWEVER THE SUSTAINED RATE DURATION (SRD) TIME CLOCK EXPIRED AND THERAPY WAS DELIVERED. THERAPY WAS EXHAUSTED AFTER SEVERAL ROUNDS OF ANTITACHYCARDIA PACING (ATP) AND SHOCK THERAPY. THE RHYTHM ACCELERATED INTO THE VENTRICULAR FIBRILLATION ZONE. THE RHYTHM EVENTUALLY SLOWED ON ITS OWN. TECHNICAL SERVICES REVIEWED DEVICE PROGRAM SETTINGS AND RECOMMENDED EXTENDED THE SRD TIMER. THE DEVICE REMAINS IN SERVICE. THERE WAS NO PERMANENT PATIENT HARM REPORTED.

    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
    314043 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR E102| 0185