BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RES-Q MICRON

    MDR report key: 2050199 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03068
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 28, 1998
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    PMA / PMN Number
    P940008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RES-Q MICRON IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT ANGLETON/ST. PAUL 101-09

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)| 0125| 1782| (B)(4)