BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3232699 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-09150
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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    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 RECEIVED THAT THE CAUSE OF HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS WAS NOT DETERMINED AND THEY COULD NOT REPLICATE THE ISSUE. A LEAD INTEGRITY TEST VIA COMMANDED SHOCK WAS NOT DONE. HENCE, THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT VIA REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) EXHIBITED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES WHICH APPEARED TO BE APPROPRIATELY DETECTED AND NO THERAPIES WERE DELIVERED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334533 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0292| E162| 4136