BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3053311 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05206
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED AND EXPLAINED THE CLINICAL OBSERVATIONS TO THE CALLER. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SHOWED 5.5 YEARS OF REMAINING LONGEVITY AND THE GAS GAUGE WAS AT THE 3/4 FULL MARK. THE DEVICE OUTPUTS WERE THEN DECEASED AND THE LONGEVITY REMAINING INCREASED TO 7 YEARS, HOWEVER, THE GAS GAUGE DID NOT MOVE UP TO THE FULL MARK. THE CALLER STATED THE CONFLICTING INDICATORS ARE MISLEADING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156203 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4136| K173| 4469| K172