BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2173305 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10941
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 11, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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, THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF DEVICE MEMORY NOTED THE DEVICE HAD RECORDED ONE OR TWO FAULTS THAT WERE MOST LIKELY CAUSED BY THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED FOR A BI-VENTRICULAR DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE EXPERIENCED DIZZINESS AND SYNCOPE. UPON INTERROGATION OF THE DEVICE, THE ELECTROGRAM SHOWED THAT THE DURATION OF THE EVENT WAS GREATER THAN TWO HOURS DURING THE TIME THE PATIENT REPORTED SYMPTOMS. THE PHYSICIAN PROGRAMMED THE DEVICE TO MONITOR ONLY TO SEE IF ARRHYTHMIAS COULD BE CAPTURED AND STORED A TRUE VENTRICULAR TACHYCARDIA (VT) EPISODE. A NON-INVASIVE STIMULATED PROCEDURE WAS TO BE PERFORMED TO PROGRAM THE ZONE RATE CORRECTLY. TECHNICAL SERVICES VERIFIED NORMAL DEVICE OPERATION.

    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 67 YR Hospitalization| L| R E110| 0158| T165| 4087