BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2910662 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15846
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    September 25, 2012
    Report Date
    November 16, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED AND THE NON-BOSTON SCIENTIFIC LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A DF-4 RV LEAD. A LEAD FRACTURE WITH THE NON-BOSTON SCIENTIFIC LEAD WAS REPORTED. THE DEVICE WAS ALSO EXPLANTED AND REPLACED WITH A DF-4 COMPATIBLE DEVICE. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED HIGH PACING IMPEDANCES ON A NON-BOSTON SCIENTIFIC LEAD. NO OTHER OUT OF RANGE IMPEDANCES WERE NOTED. IMPEDANCES HAD RANGED FROM 500 TO 1900 OHMS AND NO NOISE WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17845 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 6947| 1860| E102