MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9100

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 06/06/2016

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 prior radiation, chemotherapy, prior surgeries affection skin integrity, and underlying cancer disease.Wound infection and wound dehiscence were not reported as adverse events in the ef-11 recurrent gbm pivotal trial.In the commercial program, wound infection has been reported by <1% of patients and wound dehiscence has been reported by <1% of patients to date.

Event Description

Patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2016.On (b)(6) 2016, the patient underwent a craniotomy for a tumor resection due to gbm progression.The patient temporarily discontinued optune therapy during the healing process and resumed optune therapy on (b)(6) 2016.On (b)(6) 2016 novocure was informed by the spouse that the patient had temporarily discontinued optune therapy due to an open wound on the scalp.The patient was hospitalized on (b)(6) 2016 and underwent a wound debridement at the resection site.The bone flap was removed due to a potential bone infection.Surgical laboratory tests were positive for staphylococcus epidermidis and the patient was treated with antibiotics (ciprofloxacin, linezolid).The patient was discharged home on (b)(6) 2016.Per prescribing physician, the event was possibly related to optune therapy; however the hospital summary provided also noted a skin defect due to radiation dermatitis.

• 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: 6072517
• MDR Text Key: 59011047
• Report Number: 3009453079-2016-00076
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/02/2016

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-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 8 MO
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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: LOMUSTINE; PROCARBAZINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR