BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX MRI

    MDR report key: 8784160 · Received July 12, 2019

    Report

    Report Number
    2649622-2019-12071
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    November 14, 2018
    Report Date
    July 12, 2019
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00613994657367
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 39565-65 LEAD IMPLANTED: (B)(6) 2011, 97702 IPG IMPLANTED: (B)(6) 2016. 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 ATRIAL (RA) LEAD EXHIBITED INTERMITTENT ATRIAL UNDERSENSING. THE 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
    577606 CAPSURE FIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52 00613994657367

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 6947M62 LEAD, 459878 LEAD, DTBA1QQ CRT-D