BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 7190417 · Received January 15, 2018

    Report

    Report Number
    2124215-2017-20148
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    September 1, 2015
    Report Date
    October 11, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN-SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A GRADUAL RISE IN SHOCK IMPEDANCES OVER THE PAST FEW YEARS, AND WERE NOW GREATER THAN 125 OHMS. IT WAS NOTED THAT THE PAST FEW MONTHS THEY HAD RISEN TO APPROXIMATELY 150 OHMS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PLAN WITH THE PHYSICIAN WAS TO DELIVER A COMMANDED SHOCK AND DEFIBRILLATION THRESHOLD (DFT) TESTING FOR SAFETY MARGIN. FURTHER INFORMATION WAS RECEIVED THAT A 23J COMMANDED SHOCK WAS PERFORMED AND SUCCESSFUL. THE COMMANDED IMPEDANCES WERE 140-147 OHMS AND DEFIBRILLATION THRESHOLD (DFT) TEST IMPEDANCE WAS 105 OHMS. THE OUT OF RANGE IMPEDANCE ALERT WAS INCREASED TO 175 OHMS, AND PLAN WAS TO MONITOR PATIENT ON REMOTE MONITORING SYSTEM. THE DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33187 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R