BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4140041 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16266
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE CONFIRMED IT WAS OPERATING IN SAFETY CORE AND THAT BOTH BRADY AND TACHY THERAPY REMAINED AVAILABLE. REVIEW OF DEVICE MEMORY IDENTIFIED A FAULT. THE FAULT RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE CORRUPTED MEMORY WAS CORRECTED IN THE LABORATORY AND THE DEVICE REVERTED TO NORMAL OPERATION. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED TO THE HOSPITAL AFTER A SYNCOPAL EPISODE. UPON INTERROGATION IT WAS NOTED THAT THE DEVICE WAS IN SAFETY MODE. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620280 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND J176

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R J176