BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871185 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18121
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A COLLAPSED LUNG AROUND THE TIME OF THE IMPLANT PROCEDURE. AT THIS TIME, IT IS UNKNOWN WHEN THE COLLAPSED LUNG OCCURRED. ADDITIONAL INFORMATION FROM THE PHYSICIAN'S REPORT INDICATED THAT THE PATIENT'S POST-PROCEDURE CHEST X-RAY SHOWED THE DEVICE WAS IN PLACE WITH NO PNEUMOTHORAX AND THE PATIENT'S LUNGS WERE CLEAR. THE PHYSICIAN'S REPORT HAD AN ADDENDUM WHICH STATED THAT, ACCORDING TO A CHEST X-RAY, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PNEUMOTHORAX RESOLVED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 4549| 0158| 4087| H170