BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3904520 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-13154
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVISION PROCEDURE WAS SUBSEQENTLY PERFORMED AND THE PACE-SENSE PORTION OF THE COMPETITIVE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. A NEW PACING LEAD WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO VISUAL OBSERVATION OF LEAD FAILURE, EITHER BY DIRECT VISUALIZATION OR FLUOROSCOPY. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO FURTHER ADVERSE EVENTS FOR THE PATIENT. SHE WAS DISCHARGED HOME THE FOLLOWING DAY. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXHIBITING NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL WHEN THE PATIENT WAS AT REST. THE NOISE WAS BEING OVERSENSED, WHICH RESULTED IN SYNCOPAL EPISODES. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS AND THRESHOLD MEASUREMENTS WERE STABLE. THE PACING IMPEDANCE MEASUREMENTS HAVE VARIED BETWEEN 400 AND 800 OHMS. THE DEVICE SENSITIVITY WAS INCREASED AND A REVISION PROCEDURE WILL BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384599 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| O N161| C154DWK| 4195| 6947| 5076