BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043305 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03716
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD INDICATING THE IMPLANT PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. A CHEST X-RAY HAD BEEN COMPLETED AFTER THE PROCEDURE WHICH REVEALED A PLEURAL EFFUSION WHICH REQUIRED A CHEST TUBE. THE PATIENT WAS FOLLOWED A FEW WEEKS LATER AND THE EFFUSION WAS RESOLVED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S LUNG WAS PUNCTURED DURING THE IMPLANT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147364 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4076| N140| 0295| MISMATCH