BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4970932 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08268
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 14, 2015
    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 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WEAKNESS AND DYSPNEA. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A VEGETATION IN THE RIGHT VENTRICLE AND ON THE RIGHT VENTRICULAR LEAD. BLOOD CULTURES WERE POSITIVE FOR METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514292 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 4298-88 LEAD, 6935M55 LEAD, DTBA1QQ ICD