BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161851 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11387
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 28, 2014
    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 A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 5076-52, LEAD, (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS AFTER IMPLANT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED. THE PATEINT IS ENROLLED IN (B)(4). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT BLOOD CULTURES SHOWED STAPHYLOCOCCUS AUREUS. ECHOCARDIOGRAM RESULTS WERE AS FOLLOWS: EJECTION FRACTION 58%, MITRAL VALVE BIOPROSTHESIS-SEVERE STENOSIS AND SIGNIFICANT REGURGITATION-3 +, THE FRONT TIP OF THE BIOPROSTHESIS VEGETATION. THE PATIENT WAS HOSPITALIZED, RECEIVED INTRAVENOUS (IV) MEDICATION, AND THE EVENT WAS CONSIDERED RESOLVED SEVEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640345 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R EN1DR01 IPG