BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3040780 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02946
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND THE POSSIBILITY OF AN INTERACTION BETWEEN THE DEVICE AND THE PATIENT'S BILEVEL POSITIVE AIRWAY PRESSURE(BIPAP) MACHINE WAS DISCUSSED. WHEN THE PATIENT WAS BROUGHT INTO THE OFFICE FOR EVALUATION, THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE NOT ABLE TO BE REPRODUCED AND NO NOISE WAS SEEN ON THE LEAD. SUBSEQUENTLY NO X-RAY WAS TAKEN AND NO FURTHER TESTING WAS PERFORMED. THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT WAS ISSUED BY THE REMOTE HOME MONITORING SYSTEM FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. ELECTROMAGNETIC INTERFERENCE (EMI) IS STILL THOUGHT TO BE THE CAUSE OF THE OUT OF RANGE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143117 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR E160| 0296