BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053570 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04304
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    June 18, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO HIGH RIGHT VENTRICULAR (RV) IMPEDANCES. THE ALERT WAS DISCUSSED WITH THE PATIENT'S CLINIC. ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION WAS BEING DISCUSSED; HOWEVER, NOTHING HAS BEEN SCHEDULED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ELECTIVELY EXPLANTED OVER FOUR YEARS LATER FOR REPORTED NORMAL BATTERY DEPLETION. A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED. THE ICD WAS RETURNED FOR ANALYSIS.

    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 75 YR E110| T165| 5076| 0185