BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 9348332 · Received November 20, 2019

    Report

    Report Number
    2649622-2019-21589
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    August 2, 2019
    Report Date
    November 20, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00885074200682
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 0158 LEAD, IMPLANTED: (B)(6) 2005, C4TR01 CRT-P, IMPLANTED: (B)(6) 2005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RA LEAD EXHIBITED BIPOLAR LEAD IMPEDANCE WARNINGS. THE RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143147 CAPSUREFIX NOVUS MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652 00885074200682

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR