BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX MRI

    MDR report key: 12583231 · Received October 6, 2021

    Report

    Report Number
    2649622-2021-20053
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 18, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00613994657374
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: W1DR01 IPG, IMPLANTED: (B)(6) 2021; 3889-33 MGU LEAD, IMPLANTED: (B)(6) 2018; 3058 MGU IPG, IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD REMAINS 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
    1483652 CAPSURE FIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MPRI 5086MRI58 00613994657374

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 5086MRI52 LEAD.