BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-09860

    MDR report key: 2170325 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09860
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ATTEMPTED IMPLANT PROCEDURE, AFTER ONE HOUR AND TWENTY MINUTES, THE PHYSICIAN ELECTED TO DISCONTINUE THE IMPLANT PROCESS AS HE WAS UNABLE TO OBTAIN VEIN ACCESS. THE SCRUB NURSE MADE A COMMENT THAT SHE SUSPECTED A PNEUMOTHORAX OCCURRED, HOWEVER THIS WAS NOT EVIDENT FROM FLUOROSCOPY. THE PATIENT PRESENTED FINE WITH NO FURTHER ISSUES. THE PHYSICIAN WILL ATTEMPT A SECOND APPROACH AT A DIFFERENT SITE AT A LATER TIME.

    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 Life Threatening