BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 6007990 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06235
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 29, 2016
    Report Date
    July 29, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    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 ANALYSIS OF THE DEVICE MEMORY INDICATED AN ISSUE WITH DIAGNOSTIC AND DATA COLLECTION. IT WAS NOTED THE RATE HISTORGRAMS AND QUICKLOOK HAD NO DATA FOR THE ATRIAL AND VENTRICULAR PACING PERCENTAGES; NOTED THE DEVICE WAS PROGRAMMED TO VVIR, SO NO ATRIAL MARKERS ON THE EGM CHANNEL, WHICH IS NEEDED TO CALCULATE THE A-V TIME AND SHOW THE PERCENT DIAGNOSTICS.

    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 APPROXIMATELY ONE MONTH AFTER THE IMPLANT PROCEDURE, THE PERCENTAGE OF PACING DATA WAS NOT AVAILABLE IN THE QUICK LOOK OBSERVATIONS, ALONG WITH THE INABILITY TO SEE THE ATRIAL CHANNEL. IT WAS NOTED THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROGRAMMED TO VVIR MODE WITH AN ATRIAL SENSITIVITY OF 4.00 MV, THEREFORE, THE DEVICE DID NOT SENSE THE ATRIAL MARKERS IN THE FIRST ELECTROGRAM (EGM) CHANNEL AND THE ATRIAL AND VENTRICULAR PACING PERCENTAGES WERE MISSING IN THE STATISTICAL DATA. THE IPG 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
    658109 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 5086 LEAD, 5086 LEAD