BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3771409 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09082
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FOR THIS SYSTEM DUE TO THE DEVICE BEING IN SAFETY CORE MODE. ADDITIONALLY, PAYLOADS WERE UNSUCCESSFUL DUE TO THE DEVICE GOING INTO SAFETY CORE MODE. THE PATIENT DENIED HAVING ANY RADIATION THERAPY OR A MEDICAL RESONANCE IMAGING (MRI) AND DOING NOTHING OUT OF THE ORDINARY. THE PATIENT DID REPORT FEELING SOME TWITCHING IN HER POCKET AREA WHICH COULD HAVE RESULTED FROM THE UNIPOLAR PACING DUE TO SAFETY MODE. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249174 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4470| K062