BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 6009609 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-13507
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 28, 2016
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO EMI (ELECTROMAGNETIC INTERFERENCE)/NOISE. NOISE WAS RECORDED ON A VENTRICULAR ELECTROGRAM FOR VENTRICULAR TACHYCARDIC NON-SUSTAINED (VT-NS) EPISODES. THESE EPISODES WERE RECORDED ON (B)(6) 2016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS NOTED ON BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS ON A REMOTE MONITOR TRANSMISSION. TROUBLESHOOTING COULD NOT REPRODUCE THE NOISE DURING AN IN-OFFICE CHECK AND IT IS UNCLEAR IF IT IS AN ISSUE WITH BOTH LEADS, THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) DEVICE HEADER, OR IF AN EXTERNAL SOURCE WAS RESPONSIBLE. BOTH LEADS AND THE DEVICE 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
    657359 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 66 YR RVDR01 IPG, 5086MRI45 LEAD