BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE

    MDR report key: 6932100 · Received October 9, 2017

    Report

    Report Number
    2124215-2017-14721
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    August 11, 2017
    Report Date
    November 22, 2017
    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

    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 BRADYCARDIA THERAPY REMAINED AVAILABLE, AS DESIGNED. REVIEW OF DEVICE MEMORY IDENTIFIED FAULTS RECORDED ON (B)(6)-2017. THESE FAULTS CAUSED THE DEVICE TO REVERT TO SAFETY MODE. THE DEVICE CASE WAS REMOVED TO FACILITATE INSPECTION OF THE INTERNAL COMPONENTS. DETAILED LABORATORY TESTING ISOLATED THE ROOT CAUSE OF THE FAULTS TO A DEGRADED DIGITAL INTEGRATED CIRCUIT COMPONENT.

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY FOLLOWING AN UNEVENTFUL IMPLANT, THIS DEVICE EXHIBITED A FAULT CODE ERROR MESSAGE UPON INTERROGATION. THE MESSAGE WAS INDICATIVE OF THE PRODUCT IN SAFETY MODE AND RESULTED IN DEVICE EXPLANT. THE EXPLANTED DEVICE IS INTENDED TO BE RETURNED FOR LABORATORY ANALYSIS. NO RESULTING ADVERSE PATIENT EFFECTS WERE REPORTED AND ANOTHER DEVICE OF SAME MODEL TYPE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709011 ACCOLADE IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND L211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention