BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 4882808 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07117
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    April 25, 2015
    Report Date
    April 25, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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 RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED DEVICE DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCES MEASUREMENTS. THE DEVICE WAS PROGRAMMED DISTAL COIL TO CAN WITH RESULTING SHOCK IMPEDANCE MEASUREMENTS OF 69-70 OHMS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WHICH WAS SUCCESSFUL. THE DEVICE WAS LEFT PROGRAMMED DISTAL COIL TO CAN. 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
    427074 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R T165| E163| 4087| 0185