BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3070458 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06548
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INFORMED THE CALLER THAT THE PATIENT COULD BE BROUGHT IN FOR ADDITIONAL LEAD TESTING. FLUOROSCOPY WAS PERFORMED WHICH CONFIRMED A GOOD LEAD TO DEVICE CONNECTION. ADDITIONALLY, LEAD IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PATIENT WILL CONTINUED TO BE MONITORED VIA LATITUDE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS RECEIVED FROM THIS SYSTEM DUE TO A HIGH SHOCKING IMPEDANCE MEASUREMENT. THE MOST RECENT MEASUREMENT WAS WITHIN NORMAL LIMITS AT 75 OHMS. THIS PATIENT'S SYSTEM CONSISTS OF A BOSTON SCIENTIFIC DEVICE AND A COMPETITIVE DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172445 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR N164| H135| 1488TC| H215| 1580| 4512