BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7899782 · Received September 21, 2018

    Report

    Report Number
    2649622-2018-15538
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    February 16, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169550759
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED CENTRAL VENOUS STENOSIS AND SUPERIOR VENA CAVA (SVC) SYNDROME DUE TO OCCLUSION OF THE BRACHIOCEPHALIC AND SCV VEINS BY THEIR RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE PATIENT UNDERWENT AN ANGIOPLASTY AND HAD THEIR DIALYSIS CATHETER MOVED TO A NEW LOCATION. THE RA, RV, AND LV LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE ADAPT RESPONSE 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
    739702 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45 00643169550759

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R