BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3904528 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08447
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION THAT DEVICE EXHIBITED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR CHANNEL. ADDITIONALLY, THERE WERE FLUCTUATING IMPEDANCE MEASUREMENTS BETWEEN 500 AND 1000 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS SUSPECTED THE CLINICAL OBSERVATIONS WERE A RESULT OF THE RESPIRATORY SENSOR. AS A RESULT, THE SENSOR WAS TURNED OFF. AN X-RAY WAS PERFORMED AND NOTED NO ANOMALIES. THE PATIENT WILL BE MONITORED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384063 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F162

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR F162| MISMATCH| 0292