BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1945765 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20467
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT AFTER THE DEVICE WAS EXPLANTED FOR INFECTION, A NEW LEAD WAS IMPLANTED ON THE OPPOSITE SIDE AND INSERTED INTO THE SAME PACEMAKER. THE PREVIOUSLY EXPLANTED DEVICE WAS LEFT OUTSIDE THE PATIENT'S BODY AND USED IN AN OFF-LABEL MANNER AS A TEMPORARY PACEMAKER UNTIL THE INFECTION CLEARS AND A NEW DEVICE CAN BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R S606| S603| 4086| 4472| 4136| 4087| 4034| 4479| 1276