BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 4132192 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15526
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    January 20, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 ADDITIONAL INFORMATION THAT THIS PATIENT¿S SYSTEM IS CONTINUING TO EXHIBIT MULTIPLE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. THE CAUSE OF THIS ISSUE HAS NOT BEEN CONCLUSIVELY DETERMINED AND NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE SYSTEM REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH SHOCK IMPEDANCE OF GREATER THAN 125 OHMS. AT THIS TIME, ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED FROM THE FIELD AND THE CAUSE OF THE IMPEDANCE ISSUE REMAINS UNKNOWN. NO INTERVENTION HAS BEEN PERFORMED AND THE ICD AND RV CONTINUE TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613080 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR E161| 0181