BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE

    MDR report key: 6025728 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-15728
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    UDI-DI
    00802526559150
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED A SYNCOPAL EPISODE. REVIEW OF STORED DEVICE MEMORY NOTED NO STORED EPISODES THAT CORRELATED WITH THE EPISODE, HOWEVER, THE CAUSE OF SYNCOPE WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679597 ACCOLADE IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND L300 00802526559150

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening 4137| L300