BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4161074 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02327
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED MEAN ESTIMATED LONGEVITY AS OF (B)(4) 2014 DEVICE DATA APPROXIMATELY 39 MONTHS. ESTIMATE LOW BECAUSE THE CURRENT IS NOT STEADY, LIKELY DUE TO THE VARIABLE VENTRICULAR PACE PERCENTAGE. IF PACE PERCENTAGE OR PATIENT CONDITION CHANGES ESTIMATE WILL ADJUST.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 5086MRI58 LEAD, (B)(6) 2014. (B)(4).

    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 A DEVICE CHECK OF THE IMPLANTABLE PULSE GENERATOR (IPG) INDICATED THE EXPECTED LONGEVITY OF THE DEVICE WAS SHORT AT A MINIMUM OF 2.5 YEARS AND AVERAGE OF 3 YEARS. THE DEVICE WAS CHECKED TWO DAYS LATER AND SHOWED A MINIMUM OF 6 YEARS OF THE DEVICE LONGEVITY COULD BE EXPECTED IN THE PREVIOUS SETTINGS. IT WAS ALSO NOTED THAT THERE WAS AN INCREASE IN THE VENTRICULAR LEAD THRESHOLD. 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
    642517 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR 5086MRI52 LEAD