BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153778 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06220
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) IMPLANTABLE PULSE GENERATOR 2008 (B)(6); 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BACTEREMIA INFECTION. IT WAS NOTED THAT PRIOR TO THE PROCEDURE, THE PATIENT HAD PERSISTENTLY (B)(6) AND THAT TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED MITRAL VALVE VEGETATION. THE DEVICE AND LEADS WERE EXPLANTED AND NOT 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
    255419 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R