BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE

    MDR report key: 6026743 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-11151
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    UDI-DI
    00802526559174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. IT WAS ALSO REPORTED THAT THE DEVICE WAS REPOSITIONED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676595 ACCOLADE IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND L301 00802526559174

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4135| 4136| L301