BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3905647 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11450
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A ROUTINE FOLLOW-UP, THE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD WAS GREATER THAN 200 OHMS IN MULTIPLE CONFIGURATIONS. THE CONFIGURATION WAS REPROGRAMMED TO RIGHT VENTRICULAR COIL TO RIGHT ATRIAL CAN AND THE MEASUREMENT WAS 144 OHMS. THIS PATIENT WILL CONTINUE TO BE FOLLOWED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384886 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1 0165| 4096| F163