BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3041118 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01134
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    April 9, 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

    (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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD DISPLAYED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 500 OHMS DURING THE PAST YEAR. THE MEASUREMENTS FLUCTUATE; OTHER MEASUREMENTS WERE NORMAL. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS AND RECOMMENDED FURTHER LEAD INTEGRITY TESTING BE PERFORMED. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND A DECISION WAS MADE TO FURTHER MONITOR THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO ASYSTOLE. THIS DEVICE WAS EXPLANTED, HOWEVER THERE WAS NO ALLEGATION AGAINST DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    DURING A ONE YEAR FOLLOW UP VISIT, RIGHT VENTRICULAR CHANNEL NOISE WAS NOTED. NO INAPPROPRIATE SHOCKS HAD BEEN DELIVERED DUE TO THIS ISSUE. LEAD IMPEDANCE MEASUREMENTS HAD DECREASED TWO HUNDRED OHMS. THERE WAS CONCERN THAT THERE WAS LEAD INSULATION DAMAGE. A LEAD REVISION PROCEDURE WAS PERFORMED. DURING THIS REVISION, THIS DEVICE WAS ALSO REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143004 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention 1860| 0125