BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1954169 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24355
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WHO RECEIVED THIS NEWLY-IMPLANTED DEVICE EXPERIENCED A PNEUMOTHORAX THAT MAY HAVE BEEN RELATED TO THE IMPLANT PROCEDURE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT IT WAS KNOWN THAT INITIAL ACCESS TO THE SUBCLAVIAN VEIN WAS DIFFICULT, BUT IT WAS NOT KNOWN WHAT THE CAUSE OF THE PNEUMOTHORAX WAS. A CHEST TUBE WAS PLACED OVERNIGHT TO SUCCESSFULLY RESOLVE THE CONDITION, AND REMOVED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R 4137| 4470| S603