BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2913152 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16577
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IF THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS OBTAINED: AFTER A REVIEW OF THE DATA, IT WAS THOUGHT THE DAILY LEAD MEASUREMENTS WERE IMPACTED BY THE PATIENT'S CONDITION AND MEDICATION. THERE HAD BEEN NO RECORDED EPISODES SINCE IMPLANT. THE AMPLITUDE, PACE AND SHOCK IMPEDANCE REVEALED THE SAME TRENDS. A SLIGHT DECREASE WAS NOTED DURING THE PREVIOUS MONTH AND HAVE STARTED TO INCREASE SINCE THEN. ONE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND UNKNOWN RIGHT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A FOLLOW UP VISIT WAS PERFORMED. THE INTERROGATION REVEALED THE MEASUREMENTS HAD DECREASED AND THE OUT OF RANGE MEASUREMENTS CORRESPONDED TO THE PATIENT'S CONDITION. A DECISION WAS MADE TO LEAVE THIS DEVICE AND BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD IMPLANTED AND IN SERVICE. DIRURETICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19671 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1