BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4139020 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16267
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. DETAILED EXAMINATION OF THE DEVICE MEMORY SHOWED THAT THE DEVICE WENT INTO SAFETY MODE ON (B)(6) 2014. 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 WITH NO FURTHER ERRORS NOTED. THE DEVICE WAS PUT THROUGH AND PASSED THE RETURNED PRODUCT TESTING. THIS INVOLVED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. DESPITE ADDITIONAL TESTING, THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). THE LOCAL REPRESENTATIVE HAD BEEN CONTACTED BY THE PHYSICIAN TO INTERROGATE THIS DEVICE. THE DEVICE WAS INTERROGATED AND WAS FOUND IN SAFETY MODE PACING (72.5 PPM). THE DISPLAYED CODES (1,2,3) ARE OXC. TS SERVICES RECOMMENDED DEVICE REPLACEMENT. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE DEVICE WAS EXPLANTED AND REPLACED. THE EXPLANTED DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620054 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4087| K173| 4086