BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 7459770 · Received April 25, 2018

    Report

    Report Number
    3002807576-2018-00101
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    July 8, 2016
    Report Date
    May 16, 2018
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A SOFTWARE ERROR. THIRTY-TWO PARITY ERRORS OCCURRED. CORRECTION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A RESET. AFTER A REVIEW OF THE DEVICE REPORT IT WAS DETERMINED THAT THE IPG HAD NO ELECTRICAL RESET BUT HAD PARITY ERRORS AND SINGLE BITS OF THE MEMORY WERE CORRUPT. THE LOSS OF DATA WAS ONLY INSIDE THE NON-CRITICAL DIAGNOSTIC STORAGE AREA AND THEREFORE THE IPG WILL CONTINUE TO OPERATE NORMALLY. THE DEVICE 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
    304323 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention