BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4832230 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05120
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    June 13, 2013
    Report Date
    March 23, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POCKET INFECTION OCCURRED. THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED, AFTER CONFIRMATION OF INFECTION. POSITIVE BLOOD CULTURES CONFIRMED STAPHYLOCOCCUS AUREUS AS THE CAUSATIVE MICROBE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379238 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R EN1DR01 IPG, 5076-52 LEAD