BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-12459

    MDR report key: 1771375 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12459
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    ODL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN ADDITIONAL EVENT DETAILS WERE UNSUCCESSFUL AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AN UNSPECIFIED MALFUNCTION OF THIS PACEMAKER WAS SUSPECTED. THE PHYSICIAN WAS REQUESTING AN ONSITE VISIT FOR DEVICE EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODL GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1