BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905300 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10326
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    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 BRADY THERAPY REMAINED AVAILABLE. REVIEW OF DEVICE MEMORY IDENTIFIED THREE FAULTS. THE FAULTS 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.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS PACEMAKER WAS OBSERVED TO BE IN SAFETY MODE AND EXHIBITED THREE FAULT CODES INDICATING AN UNRECOVERABLE DEVICE RESET. IT WAS NOTED THAT THE PATIENT HAD BEEN IN CONTACT WITH A WELDING MACHINE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382140 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R K063| 4137| 4135