BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-05734

    MDR report key: 2059947 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05734
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE IMPLANTED IN THIS PATIENT AT THIS TIME. 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 WHILE ATTEMPTING TO GAIN ACCESS DURING AN IMPLANT PROCEDURE, THIS PATIENT DEVELOPED A PERICARDIAL EFFUSION AND SUBSEQUENTLY CARDIAC TAMPONADE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN EXTERNAL PACING. AN ADDITIONAL SURGICAL PROCEDURE MAYBE SCHEDULED AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DWS GUIDANT PUERTO RICO BV ACCESSORY

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening