BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTTF-100A

    MDR report key: 3779093 · Received April 16, 2014

    Report

    Report Number
    3009453079-2014-00037
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P0100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBER #: (B)(4). PRESCRIBING PHYSICIAN AND TREATING SURGEON ATTRIBUTED THE CAUSE OF THE SKIN ULCER TO NOVOTTF THERAPY. NOVOCURE MEDICAL ASSESSMENT IS THAT NOVOTTF THERAPY CONTRIBUTED TO THE SKIN ULCER. OTHER CONTRIBUTING FACTORS INCLUDE: CONCOMITANT THALIDOMIDE (CARRIES A WARNING FOR POSSIBLE WOUND HEALING INTERFERENCE. SOURCE: THALIDOMIDE PRESCRIBING INFO), CONCOMITANT VALGANCICLOVIR (KNOWN ADVERSE REACTIONS INCLUDE WOUND DEHISCENCE. SOURCE: VALGANCICLOVIR PRESCRIBING INFO), PRIOR RADIATION, CHEMOTHERAPY AND SURGERY AFFECTING SKIN INTEGRITY AND PRIOR BEVACIZUMAB USE (BEVACIZUMAB IS A VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITOR WHICH CARRIES A BLACK BOX WARNING FOR SURGERY AND WOUND HEALING COMPLICATIONS INCLUDING WOUND DEHISCENCE. SOURCE: BEVACIZUMAB PRESCRIBING INFO). SKIN REACTION AND SKIN ULCER ARE KNOWN ADVERSE EVENTS WITH USE OF NOVOTTF THERAPY WITH AN INCIDENCE OF 16% FOR DEVICE SKIN REACTIONS AND 1% FOR SKIN ULCERS REPORTED IN THE PIVOTAL PHASE III CLINICAL TRIAL IN PTS WITH RECURRENT GBM. THE IFU INCLUDES A PRECAUTION AGAINST PLACING TRANSDUCER ARRAYS OVER AREAS WHERE CRANIOTOMY SCREWS OR PLATES CAN BE FELT DUE TO RISK FOR INCREASED SKIN DAMAGE. PRESCRIBERS AND PTS ARE EDUCATED ON THIS DURING THEIR TRAINING.

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA (GBM) BEGAN NOVOTTF THERAPY ON (B)(6) 2013. ON (B)(6) 2014, NOVOCURE WAS INFORMED THAT THE PT HAD PERMANENTLY DISCONTINUED NOVOTTF THERAPY DUE TO A SCALP ULCERATION WHICH REQUIRED SURGERY. PER HOSPITAL SUMMARY PROVIDED BY PRESCRIBING PHYSICIAN, PT HAD PRESENTED TO THE HOSPITAL ON (B)(6) 2014 WITH A COMPLEX OPEN WOUND OF THE LEFT TEMPORAL AREA WITH EXPOSED CRANIUM, DURA AND HARDWARE. ON (B)(6) 2014, PT UNDERWENT EXCISIONAL DEBRIDEMENT OF THE WOUND, REMOVAL OF HARDWARE (EXPOSED PLATE) AND ROTATION OF A LARGE INFERIORLY BASED SCALP FLAP TO COVER THE WOUND AND RECONSTRUCT THE LEFT TEMPLE AREA. TEMPORARY JACKSON-PRATT DRAIN WAS PLACED AND REMOVED PRIOR TO DISCHARGE. WOUND WAS NOTED TO BE INFECTED PER SURGERY NOTES (NO FURTHER INFO PROVIDED). PT WAS KEPT ON IV ANTIBIOTICS AND WOUND WAS HEALING WELL AT TIME OF REPORT. PT WAS DISCHARGED ON (B)(6) 2014 ON ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233956 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R