BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 8629223 · Received May 21, 2019

    Report

    Report Number
    3009453079-2019-00116
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 26, 2019
    Report Date
    January 7, 2022
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 23, 2021, NOVOCURE DISCOVERED THAT THE INITIAL SUBMITTED MEDICAL DEVICE REPORT HAD A TYPO IN THE MODEL NUMBER FOR THE OPTUNE DEVICE IN SECTION D4-SUSPECT MEDICAL DEVICE MODEL NUMBER. CORRECTED MODEL NUMBER IS TFH9100.

    Additional Manufacturer Narrative · 1

    NOVOCURE'S MEDICAL OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE EVENT CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE AND WOUND INFECTION IN THIS PATIENT ALSO INCLUDE CONCOMITANT DEXAMETHASONE (IMPAIRED WOUND HEALING AND INCREASED RISK OF INFECTION ARE LISTED AS SIDE EFFECTS. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION), PRIOR RADIATION, CHEMOTHERAPY, AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND INFECTION IS AN EXPECTED EVENT WITH DEVICE USE AND WAS REPORTED AS AN ADVERSE EVENT IN THE (B)(6) TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN BOTH ARMS OF THE TRIAL (<1% AND <1% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY). WOUND DEHISCENCE WAS REPORTED IN THE OPTUNE/TMZ ARM OF THE TRIAL (<1%) ONLY.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2019. ON APRIL 29, 2019, SPOUSE REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2019. WHEN REMOVING THE TRANSDUCER ARRAYS FROM THE SCALP ON (B)(6) 2019, IT WAS DISCOVERED THAT AN ABSCESS HAD FORMED ON THE CRANIOTOMY RESECTION SCAR SITE (LAST RESECTION (B)(6) 2018). ON (B)(6) 2019, PATIENT UNDERWENT WOUND REVISION SURGERY AND REMOVAL OF THE BONE FLAP. PER PRESCRIBING PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO LATE SURGERY INFECTION AND HIGH DOSE STEROID MEDICATION (DEXAMETHASONE, 24 MG DAILY) AND UNRELATED TO OPTUNE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419775 OPTUNE OPTUNE NZK NOVOCURE, INC. TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R DEXAMETHASONE.| LEVETIRACETAM.| TEMOZOLOMIDE.| DEXAMETHASONE| LEVETIRACETAM| TEMOZOLOMIDE