BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3971341 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14859
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    January 31, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DISPLAYED NOISE THAT WAS OVERSENSED. OVERSENSING LED TO PACING INHIBITION WITH ASYSTOLE OF APPROXIMATELY 3 SECONDS AS SEEN ON STORED ELECTROGRAMS (EGM). RV LEAD IMPEDANCE AND THRESHOLD WERE NOTED TO BE GOOD AND STABLE. THE NOISE WAS NOT ABLE TO BE RECREATED WITH ARM MOVEMENTS OR ISOMETRICS. THE DEVICE WAS REPROGRAMMED TO 0.7MV. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446378 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 4470| N161| 0184| 4555| T165| MISMATCH