BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVO-TTF-100A

    MDR report key: 2818416 · Received October 4, 2012

    Report

    Report Number
    3009453079-2012-00006
    Event Type
    Other
    Date Received
    October 4, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN IRRITATION/DEVICE SITE REACTION AND SKIN ULCER IS A KNOWN ADVERSE EVENT WITH USE OF THE NOVOTTF DEVICE WITH AN INCIDENCE OF (B)(4) FOR DEVICE SITE REACTION AND (B)(4) FOR SKIN ULCER REPORTED IN THE PIVOTAL PHASE III CLINICAL TRIAL IN PTS WITH RECURRENT GBM. THE IFU INCLUDES A PRECAUTION ABOUT PLACING TRANSDUCER ARRAYS OVER AREAS WHERE CRANIOTOMY SCREWS OR PLATES CAN BE FELT DUE TO RISK OF INCREASE SKIN DAMAGE. PRESCRIBERS AND PTS ARE EDUCATED ON THIS DURING THEIR TRAINING. THIS ADVERSE EVENT, SKIN ULCER, IS RELATED TO THE NOVOTTF DEVICE. CONTRIBUTING FACTORS INCLUDE HISTORY OF PRIOR RADIATION AND SURGERY AFFECTING SKIN INTEGRITY AND PLACEMENT OF TRANSDUCER ARRAYS OVER A SCREW AT THE SITE OF THE PRIOR CRANIOTOMY. PT WAS NOT REPORTED TO BE ON STEROIDS (TOPICAL OR SYSTEMIC) AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA RECEIVING NOVOTTF THERAPY DEVELOPED SKIN BREAKDOWN AND SKIN ULCER UNDER TRANSDUCER ARRAYS AT SITE OF SCREW FROM PRIOR CRANIOTOMY REQUIRING ADMISSION TO HOSP FOR DEBRIDEMENT AND CLOSURE. NO ANTIBIOTICS WERE REQUIRED. AS OF (B)(6) 2012, HEALING WELL, AS PER TREATING MD. NOVOTTF TREATMENT HAS BEEN INTERRUPTED UNTIL AREA HEALS. AS PER TREATING MD, PT HAD "MINOR ULCER" RELATED TO THINNING OF OVERLAYING SKIN FROM SURGERY AND RADIATION AND USE OF NOVOTTF WITHOUT ARRAY CHANGE FOR 5 DAYS. AS OF (B)(6) 2012, NOVOTTF THERAPY HAS NOT BEEN RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVO-TTF-100A NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization KEPPRA| ZOFRAN| OMEPRAZOLE| CONCERTA| SERTRALINE