BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 3905614 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12042
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXHIBITED NOISE AND OVERSENSING. PACING INHIBITION WITH ASYSTOLE GREATER THAN TWO SECONDS WAS NOTED. THE ELECTROGRAM (EGM) STRIP WAS REVIEWED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND POTENTIAL CAUSES WERE DISCUSSED. THE PHYSICIAN REPROGRAMMED THE RV SENSITIVITY, AND THE PLAN WAS TO RE-EVALUATE IN A FEW WEEKS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE NOISE AND OVERSENSING HAS NOT BEEN DETERMINED. THE PATIENT DID NOT APPEAR AT THE CLINIC FOR HER FOLLOW-UP APPOINTMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383950 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND D012

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0292| D012| 4470