BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX MRI

    MDR report key: 8845470 · Received July 31, 2019

    Report

    Report Number
    2649622-2019-13441
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00613994657367
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE EXPLANTED AND RETURNED TO THE MANUFACTURER, ANALYSED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642612 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 32 YR RVDR01 IPG, 5086MRI45 LEAD