BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-18106

    MDR report key: 1875170 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18106
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 15, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS EVENT INVOLVED AN OEM MANUFACTURED RIGHT ATRIAL (RA) LEAD THAT HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO PATIENT NAME OR LEAD MODEL/SERIAL INFORMATION WAS PROVIDED. SEVERAL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION ABOUT THIS EVENT; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED IN THIS EVENT. AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT THIS EVENT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS GOING TO UNDERGO A LEAD REVISION. THE SPECIFIC LEAD BEING REVISED AND THE REASON FOR THE REVISION PROCEDURE WERE NOT PROVIDED, AND ARE UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1