BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 4210017 · Received October 29, 2014

    Report

    Report Number
    2124215-2014-19083
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 147 OHMS. AN IN OFFICE, DEVICE INTERROGATION WAS PERFORMED. THE MEASURED SHOCK IMPEDANCE DURING TESTING WAS 60 OHMS. ALL OTHER SYSTEM PARAMETERS WERE REPORTED TO HAVE CHECK OUT NORMALLY. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI). THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691552 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 0292| E160