BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-19722

    MDR report key: 1944936 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19722
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER EVENT DETAILS COULD BE OBTAINED REGARDING THIS DEVICE AND THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT SUSPECTS THERE MIGHT BE AN INFECTION OF THIS PACEMAKER POCKET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1