BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 11611121 · Received April 2, 2021

    Report

    Report Number
    3009453079-2021-00168
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    August 14, 2020
    Report Date
    April 2, 2021
    Manufacturer
    NOVOCURE, LTD.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE'S ASSESSMENT IS THAT THIS EVENT WAS RELATED TO ELECTROMAGNETIC COMPATIBILITY PROBLEM WITH THE INS. THE OPTUNE INSTRUCTIONS FOR USE CONTAINS A WARNING AGAINST USING THE DEVICE WITH ACTIVE ELECTRICAL IMPLANTED DEVICES, INCLUDING SPINAL CORD STIMULATORS. PAIN WAS REPORTED AS AN ADVERSE EVENT IN THE PIVOTAL EF-11 TRIAL IN RECURRENT GBM. MEDICAL DEVICE INTERFERENCE IS NOT AN EXPECTED EVENT WITH DEVICE USE. THERE HAVE BEEN 17 REPORTS OF MEDICAL DEVICE INTERFERENCE IN THE COMMERCIAL PROGRAM TO DATE. ELECTRIC SHOCK IS NOT AN EXPECTED EVENT WITH DEVICE USE. THERE HAVE BEEN 54 REPORTS OF ELECTRIC SHOCK IN THE COMMERCIAL PROGRAM TO DATE.

    Description of Event or Problem · 1

    AN UNKNOWN MALE PATIENT WITH GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON AN UNKNOWN DATE. ON (B)(6) 2021, DURING A REVIEW OF THE FDA MAUDE DATABASE IT WAS DISCOVERED THAT AN ADVERSE EVENT REPORT REFERRING TO OPTUNE HAD BEEN SUBMITTED BY MEDTRONIC ON (B)(6) 2020, FOR THE SURESCAN SPINAL CORD STIMULATOR (MODEL NUMBER 97712), AN IMPLANTED MEDICAL DEVICE (MEDTRONIC 3004209178-2020-15421). ON AN UNSPECIFIED DATE, THE PATIENT HAD A SPINAL CORD NEUROSTIMULATION SYSTEM (INS) IMPLANTED TO TREAT CANCER PAIN. ON (B)(6) 2020, WHEN POWERING ON THE OPTUNE DEVICE, THE PATIENT EXPERIENCED PAIN AND A SHOCKING SENSATION AT THE INS POCKET SITE ON HIS CHEST. ACCORDING TO THE MEDTRONIC REPORT, THE EVENT WAS DUE TO AN ELECTROMAGNETIC COMPATIBILITY PROBLEM WITH THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505100 OPTUNE OPTUNE NZK NOVOCURE, LTD. TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other