BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4834350 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06697
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 25, 2015
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RIGHT VENTRICLE (RV) WAS ELEVATED. ANALYST COMMENTED, WEEKLY CAPTURE MANAGEMENT SHOWS MAX VENTRICULAR THRESHOLD AT APPROX 0.9 VOLTS FROM (B)(6) 2014 THROUGH (B)(6) 2015, THEN INCREASING TO 2.5 VOLTS ON (B)(6) 2015. VENTRICULAR IMPEDANCE WAS NORMAL AND STEADY NEAR 400 OHMS THROUGHOUT RECORD. (B)(4).

    Description of Event or Problem · 1

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THERE WERE NO PERFORMANCE ISSUES WITH THE ASSOCIATED ATRIAL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP VISITS THE ATRIAL LEAD EXHIBITED DECREASE AND VARYING THRESHOLDS, AND DECREASE AND VARYING IMPEDANCE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE AND VARYING THRESHOLDS AND DECREASE AND VARYING IMPEDANCE. THE DEVICE SETTINGS WERE REPROGRAMMED, AND THE ATRIAL AND RV LEAD REMAINED IN USE. DURING ADDITIONAL L FOLLOW UP VISITS IT WAS ALSO REPORTED THAT THE ATRIAL AND RV LEAD EXHIBITED VARYING THRESHOLDS. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED HIGH THRESHOLDS, AND ADJUSTMENTS TO THE LEAD OUTPUT SETTINGS WERE MADE. THE ATRIAL AND RV LEAD REMAIN IN USE, AND THE PATIENT WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374432 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 00088 YR Required Intervention A3DR01 IPGL 5086MRI52 LEAD