BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3991314 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08193
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD SLOW DEPLOYMENT OF THE HELIX WAS NOTED, TAKING MORE THAN THE EXPECTED TURNS CAUSING PLACEMENT DIFFICULTY. THE FOLLOWING DAY IT WAS NOTED THAT THE RV LEAD HAD DISLODGED, HIGH THRESHOLDS AND HIGH IMPEDANCE WERE FOUND. SURGICAL REPOSITIONING WAS SUCCESSFUL, AND 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
    472090 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 5086MRI45 LEAD, A2DR01 IPG