BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3741304 · Received April 11, 2014

    Report

    Report Number
    2649622-2014-03126
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    December 16, 2013
    Report Date
    February 3, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # (B)(4): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED. IT WAS NOTED THAT THE ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS DECREASING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5086MRI52, IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAT HIGH THRESHOLDS, A DECREASE IN IMPEDANCE FROM APPROXIMATELY 900-950 OHMS TO APPROXIMATELY 450 OHMS, A POSSIBLE/PROBABLE MICRODISLODGMENT AND DIAPHRAGMATIC STIMULATION. THE RV LEAD WAS REVISED AND 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
    225707 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R A2DR01 IMPLANTABLE PACEMAKER