BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860845 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05284
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    IT WAS REPORTED THE PATIENT DEVELOPED A SYSTEMIC INFECTION. A BLOOD CULTURE TAKEN FROM THE PATIENT RETURNED POSITIVE. HOWEVER, THE DEVICE POCKET HAD A NEGATIVE CULTURE FOR BACTERIAL GROWTH. THE SOURCE OF THE INFECTION WAS REQUESTED BUT WAS UNKNOWN. THE DEVICE AND LEADS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342381 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R 6947 LEAD, D284DRG ICD