BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2910355 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-14388
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    September 28, 2011
    Report Date
    October 22, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED INDICATED THE PATIENT PLANNED TO BE MONITORED THROUGH NORMAL DEVICE FOLLOW-UP. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. PACING THRESHOLDS AND INTRINSIC R WAVE SENSING WERE CONFIRMED TO BE STABLE. NOISE WAS NOTED ON THE SHOCK ELECTROGRAM (EGM), BUT ONLY DURING ISOMETRICS. THERE WAS NO EVIDENCE OF ANY STORED EVENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17151 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 0185| A155| 4469| E110