BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910645 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15369
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING THE IMPLANT PROCEDURE OF THIS RIGHT VENTRICULAR (RV) LEAD, THE PATIENT SUSTAINED A PNEUMOTHORAX. THE PHYSICIAN DISCOVERED THE OBSERVATION AFTER THE SECOND FAILED SERIES OF DEFIBRILLATION THRESHOLD (DFT) TESTING. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED, AND THE PATIENT HAD SUCCESSFUL DFT AT 21 JOULES AFTER A CHEST TUBE WAS INSERTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16972 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R