BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4160829 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11736
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE ATRIAL PACING LEAD WAS VARIABLE AND ATRIAL PACING CAPTURE THRESHOLD WAS INTERMITTENT. ATRIAL CAPTURE MANAGEMENT TREND DATA SHOWS THE ATRIAL THRESHOLD HAS BEEN VARYING THROUGHOUT THE RECORD. WEEKLY PACING IMPEDANCE TREND DATA SHOWS ATRIAL LEAD IMPEDANCE HAS BEEN VARYING THROUGHOUT THE RECORD WITH SOME SPIKES TO GREATER THAN 2000 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNSTABLE THRESHOLDS AND OVERSENSING OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF). IT WAS NOTED THERE WAS A CONNECTION ISSUE BETWEEN THE LEAD AND THE DEVICE. THE LEAD WAS REVISED. THE DEVICE AND LEAD REMAIN 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
    641537 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 Hospitalization| R A3DR01 IPG