MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

Device Problems Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution to the wound complication cannot be excluded.Contributing factors for wound complication in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound complication was reported as an adverse event in the 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%) only.Review of the device logfile showed intermittent connection issues that likely contributed to the "electric sensations" reported by this patient.There was no harm associated with these sensations.

Event Description

A (b)(6) year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2020, novocure was informed by the patient's caregiver that on an unspecified day, the patient had temporarily discontinued optune therapy due to exposed cranium hardware at site of previous tumor resection (last surgical resection (b)(6) 2015).Per clinic notes provided by the prescriber, patient presented to the oncology clinic on (b)(6) 2020, with an exposed cranium hardware screw.Patient stated that the screw was exposed on (b)(6) 2019, after a scab fell off an area previously scabbed over for an extended amount of time.Patient reported "electric shocks" while using the device.Patient denied any fevers, tenderness or drainage from the affected area.As a precaution, surgical repair of the exposed hardware was put on hold for 30 days after receiving bevacizumab infusion.The prescribing physician stated that the patient was not hospitalized for the event, however wound re-closure surgery was scheduled for (b)(6) 2020.Patient planned to resume optune therapy after wound re-closure.Prescriber stated that there was no evidence of wound dehiscence or infection.Per the prescriber, the cause of the wound complication was a combination of re-radiation, bevacizumab, and lack of appropriate optune transducer array exchanges.

Manufacturer Narrative

On (b)(6) 2023, novocure discovered that the initial submitted medical device report listed the incorrect code in section h6-medical device problem code.The correct code is 2993-adverse event without identified device or use problem.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 6033191907
• MDR Report Key: 9738825
• MDR Text Key: 191841648
• Report Number: 3009453079-2020-00137
• Device Sequence Number: 1
• Product Code: NZK
• 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,Followup
• Report Date: 02/10/2023

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
• Is the Reporter a Health Professional?: No
• Device Age: 41 MO
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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: BEVACIZUMAB; CELECOXIB; FUROSEMIDE; ONDANSETRON; POTASSIUM CHLORIDE; PREGABALIN; RANITIDINE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 92 KG