MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Other contributing factors for wound complication in this patient include concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior surgeries affecting skin integrity and underlying cancer disease.Wound dehiscence was reported as an adverse event in the pivotal ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1% of patients).

Event Description

Patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2016.On may 16, 2016 the spouse reported that the patient was seen at a local hospital on (b)(6) 2016 for a possible infection to the surgical site (craniotomy (b)(6) 2015).Patient was discharged home on antibiotics (cephalexin).On (b)(6) 2016 the scab from the surgical incision site fell off exposing a 1 cm wound dehiscence and surgical hardware.No surrounding redness or erythema or infection was noted.The patient was admitted to neurosurgery for exploration and revision of wound with removal of exposed hardware.Surgical cultures were negative for infection however patient was started on empiric antibiotics as a precaution.Optune therapy was put on hold.Prescribing physician stated that the event was possibly related to the placement of the optune transducer arrays, as this may have contributed to scab removal and opening the wound despite avoiding the scab area when placing the arrays.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5708641
• MDR Text Key: 46876499
• Report Number: 3009453079-2016-00072
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 00729010798401
• UDI-Public: 0729010798401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TFH-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 16 MO
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LACOSAMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 68