BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991820 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07933
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCT: A4DR01 IPG (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANT, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. IT WAS NOTED THAT THE PATIENT HAS A PORT-A-CATH FOR INFUSIONS AND HAS HAD MITRAL AND TRICUSPID VALVE REPAIRS. THE PATIENT DEVELOPED A PERICARDIAL ABSCESS AND SYSTEMIC INFECTION REQUIRING EXPLANATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468230 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 429678 LEAD