BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2153324 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06126
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    FIVE DAYS LATER, THE PATIENT WAS BROUGHT IN FOR A REVISION. WHEN THE POCKET WAS OPENED, THE PHYSICIAN OBSERVED A LOOSE HEADER. HE PERFORMED A LOW ENERGY SHOCK AND OBSERVED IMPEDANCES OF 59 OHMS, BUT THEY GRADUALLY INCREASED TO GREATER THAN 125 OHMS. A NEW DEVICE WAS THEN PLACED AND THE SAME OUT OF RANGE IMPEDANCES WERE OBSERVED SO A NEW DEFIBRILLATION LEAD WAS IMPLANTED. THE EXPLANTED DEVICE AND LEAD ARE SCHEDULED TO BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED MINOR HEADER BOND SEPARATION. AN X-RAY CONFIRMED THE NEGATIVE DEFIBRILLATION CONNECTION WIRE WAS FRACTURED, WHICH CAUSED THE ONE OUT OF RANGE IMPEDANCE MEASUREMENT WHILE IMPLANTED. ELECTRICAL TESTING WAS THEN PERFORMED AND PASSED, EVEN AT THE FRACTURE SITE DUE TO THE HEADER BOND HOLDING THE FRACTURED SURFACES TOGETHER. ANALYSIS CONFIRMED THE OBSERVATION OF A HIGH IMPEDANCES DUE TO A FRACTURED CONNECTION WIRE BETWEEN THE HEADER AND DEVICE CASING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS DETECTED DUE TO HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 125 OHMS. TECHNICAL SERVICES BELIEVED THIS WAS A ONE OFF SITUATION AS ALL OTHER DATA LOOKED APPROPRIATE. THE PATIENT IS SCHEDULED FOR DEVICE CHECK AND AT THAT TIME, TACHY THERAPY WILL BE TURNED OFF AND FURTHER TESTING WILL BE PERFORMED TO VERIFY THE INTEGRITY OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 215 MO E102| 0181