BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162532 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12724
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE PATIENT EXPERIENCED PERFORATION OF THE RIGHT VENTRICLE AND TAMPONADE. A PERICARDIAL WINDOW WAS PERFORMED. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644734 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| L| R