BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 8257118 · Received January 17, 2019

    Report

    Report Number
    2649622-2019-00973
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 24, 2018
    Report Date
    February 13, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169550766
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: R770029 MECHANICAL VALVE, IMPLANTED: (B)(6)2007. 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 HAD SEPSIS SYNDROME AND WAS BROUGHT TO THE HOSPITAL WITH AN EPISODE OF MULTI-SYSTEM ORGAN FAILURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED ENDOCARDITIS. THE INFECTED AORTIC VALVE WAS THOUGHT TO HAVE VEGETATION AND THE VALVE WAS REMOVED AND A PORTION OF THE AORTIC GRAFT AND IMPLANTATION OF A HOMOGRAFT AORTIC VALVE AND AORTA. THE DEVICE AND LEADS WERE EXPLANTED. THE PATIENT IS A PARTICIPANT IN THE ATTAIN STABILITY QUAD CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50225 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169550766

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DTMA1QQ ICD, 479888 LEAD, 6935M62 LEAD