BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1864188 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16393
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS DETERMINED THE DEVICE DID NOT REACH ELECTIVE REPLACEMENT INDICATORS WHILE IMPLANTED. A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WAS CONDUCTED TO VERIFY THE PERFORMANCE OF THE MEMORY, PACING, DEFIBRILLATION, RECORDING AND SENSING FUNCTIONS, INCLUDING TESTS SPECIFICALLY DESIGNED TO VERIFY SENSE AMPLIFIER OPERATION ALONG WITH ITS ASSOCIATED COMPONENTS. ADEQUACY OF SETSCREW FUNCTION AND CONTACT WITH THE LEAD'S TERMINAL PIN WAS ALSO VERIFIED DURING TESTING. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS. ANALYSIS CONCLUDED THE IMPEDANCE MEASUREMENTS FROM THE DEVICE WERE NORMAL. NO ADVISORY SYMPTOMS WERE REVEALED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE DISPLAYED A RED ALERT INDICATING HIGH OUT OF RANGE RIGHT VENTRICULAR LEAD PACING IMPEDANCE MEASUREMENTS. IN ADDITION, NOISE CAUSING OVERSENSING WAS NOTED. THE PATIENT WITH THIS DEVICE HAD EXPERIENCED AN INAPPROPRIATE SHOCK. A FOLLOW UP VISIT WAS PERFORMED, INTERROGATION REVEALED MINIMAL NOISE DURING ISOMETRICS. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. AN X-RAY WAS PERFORMED, NO LEAD ISSUE WAS REVEALED. THE RIGHT VENTRICULAR LEAD'S HELIX WAS NOT EXTENDED. IT WAS THOUGHT THERE MAY BE CONNECTION ISSUE. A PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE TO FURTHER INVESTIGATE WHETHER THE ISSUE IS LEAD OR DEVICE RELATED. FURTHER INFORMATION WAS RECEIVED; DURING A FOLLOW UP VISIT, FURTHER REVIEW REVEALED NO INDICATION OF A LEAD ISSUE. IT WAS NOTED THE RIGHT VENTRICULAR LEAD HELIX WAS NOT EXTENDED. AT THIS TIME, IT IS UNKNOWN WHETHER THERE IS A CONNECTION/HEADER ISSUE OR THIS IS A LEAD RELATED ISSUE. FURTHER INTERROGATION WILL BE PERFORMED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. THE HEADER CONNECTION WAS INVESTIGATED AND MANIPULATED AND NO NOISE WAS CREATED. AS THERE WAS CONCERN REGARDING THIS DEVICE IMPLANTED SUBPECTORAL, A DECISION WAS MADE TO REPLACE THE DEVICE. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR 0158| F102| 1870