BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1944978 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20854
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    September 10, 2009
    Report Date
    August 29, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A YELLOW ALERT WAS DETECTED VIA LATITUDE FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO A PACING IMPEDANCE OF GREATER THAN 2000 OHMS. IT WAS NOTED THAT THERE WERE TWO OUT OF RANGE READINGS ON CONSECUTIVE DAYS; OTHERWISE IMPEDANCES HAVE BEEN IN THE 500 OHMS RANGE. TECHNICAL SERVICES (TS) DISCUSSED THAT SINCE THERE WERE NO OTHER OUT OF RANGE MEASUREMENTS AND THE DEVICE WAS IN VVI MODE, THEY SUGGESTED A POSSIBLE LEAD ISSUE. THEY RECOMMENDED CONTINUED MONITORING FOR NOW, AND IT WAS NOTED THIS WOULD BE DISCUSSED FURTHER WITH THE PHYSICIAN. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THE DEVICE WAS LATER EXPLANTED. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS HAD BEEN HIGH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)