BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE

    MDR report key: 6026767 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-13246
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 15, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. IT WAS ALSO REPORTED THAT THE PATIENT HAD BLOOD INFECTION. IN ADDITION, THIS PACEMAKER WAS THEN USED AS AN EXTERNAL TEMPORARY PACING DEVICE UNTIL A NEW SYSTEM WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678859 ACCOLADE IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND L101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 7742| L101| MISMATCH