BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 8621113 · Received May 17, 2019

    Report

    Report Number
    2649622-2019-08455
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    March 14, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124799
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CD3357-40C ICD; 1158T LEAD, IMPLANTED: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414120 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45 00681490124799

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 694765 LEAD