BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1962282 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00883
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    June 1, 2010
    Report Date
    June 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH OUT OF RANGE RV PACE IMPEDANCES CONTINUED TO BE OBSERVED ON THIS ICD SYSTEM. INFORMATION WAS LATER RECEIVED THAT THE CONTINUING OUT OF RANGE PACE IMPEDANCES WERE BELIEVED TO BE THE RESULT OF FIBROTIC TISSUE ENCAPSULATION AT THE LEAD TIP. SHOCK IMPEDANCES WERE NOTED TO REMAIN WITHIN NORMAL LIMITS WITH NO APPARENT NOISE ON THE SHOCK CHANNEL OF THE ICD. THE PATIENT WAS NOTED TO NOT BE PACEMAKER DEPENDENT AND CONTINUES TO BE MONITORED CLOSELY WITH NO PLANS OF SYSTEM REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS ICD AND RV LEAD ARE NO LONGER IN SERVICE. THE PACING THRESHOLD OF THE CHRONIC RV LEAD WAS NOTED TO BE HIGH AT THE TIME OF REVISION. THE ICD WAS EXPLANTED AND RV LEAD SURGICALLY ABANDONED. A NEW SYSTEM WAS SUBSEQUENTLY IMPLANTED. THE PREVIOUS DEVICE IS NOT EXPECTED FOR RETURN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT FOR AN OUT OF RANGE HIGH PACING IMPEDANCE MEASUREMENT WAS DETECTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV THRESHOLD INCREASED TO 3.5 V, AND SENSING WAS 20 MV. THE PHYSICIAN INCREASED THE OUTPUT, AND THE VALUE OF THE SHOCK IMPEDANCE WAS CONSTANT. A SHOCK INTEGRITY TEST WAS PERFORMED IN ORDER TO VERIFY THE INTEGRITY OF THE SHOCK CIRCUIT. THE TEST WAS FOUND TO BE SUCCESSFUL, AND THIS DEVICE OPERATED AS DESIGNED. THE DECISION WAS MADE TO MONITOR THE IMPEDANCE VALUES, AND PATIENT WILL ATTEND NEXT REGULAR FOLLOW-UP. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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 66 YR Hospitalization| L| R