BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991791 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07952
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 6, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT FOLLOWING AN IMPLANT SURGERY, SWELLING WAS NOTED IN THEIR LEFT ARM AND A BLOOD CLOT WAS DIAGNOSED. THE PATIENT ALSO REPORTED THAT THEIR LUNG COLLAPSED AND A CHEST TUBE WAS PLACED. IT WAS FURTHER REPORTED BY THE CLINIC, THAT A HEMOTHORAX WAS CONFIRMED AND CHEST TUBE WAS NECESSARY FOLLOWING A LEAD IMPLANT. IN ADDITION, THROMBOSIS OF THE PATIENT'S SUBCLAVIAN VEIN WAS INDICATED BY THE PHYSICIAN. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467867 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R ADDR01 IPG