BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3990085 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01816
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 INFECTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463002 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5086MRI52 LEAD, 5086MRI58 LEAD