BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2151394 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06023
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 2, 2011
    Report Date
    February 7, 2012
    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 AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND DEFIBRILLATION LEAD REMAIN IMPLANTED. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS DETECTED FOR HIGH OUT OF RANGE SHOCK IMPEDANCES. IT WAS REPORTED THAT THE PATIENT DOES NOT REGULARLY GET HIS DEVICE CHECKED SO THE CLINIC WAS GOING TO CONTACT HIM TO COME IN FOR TESTING.

    Description of Event or Problem · 1

    TEN MONTHS LATER, ANOTHER ALERT WAS DETECTED FOR LOW SHOCK IMPEDANCES OF 13 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED INFORMATION AND DISCUSSED HOW THIS SYSTEM HAS A SINGLE COIL LEAD, BUT THE DEVICE SETUP IS TRIAD FOR SHOCK VECTOR SO THEY SUSPECT THE PATIENT HAS ANOTHER NON-BOSTON SCIENTIFIC LEAD USED AS THE PROXIMAL COIL. THE LAST DELIVERED SHOCK WAS IN (B)(6) 2010 AFTER THE LEAD WAS IMPLANTED AND A NORMAL IMPEDANCE OF 40 OHMS WAS NOTED. TS DISCUSSED FURTHER THAT THIS COULD BE A START OF A LEAD ISSUE WITH THE NON-BOSTON SCIENTIFIC LEAD OR POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI) AND DISCUSSED CHECKING FOR SOURCES THAT COULD BE A CAUSE.

    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 56 YR 0125| 1746| 6937| E102| T127| 1763| 0074| 1600