MAUDE Adverse Event Report: NOVOCURE, INC. OPTUNE

Model Number TFH9100

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Post Operative Wound Infection (2446)

Event Date 07/27/2019

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that a contribution of the array placement to the event cannot be ruled out.Contributing factors for wound dehiscence and wound infection in this patient also include concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity.Wound infection is an expected event with device use and was reported as an adverse event in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).Wound dehiscence (<1%) and brain abscess (1%) were reported in the optune/tmz arm of the trial only.

Event Description

A 53 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019, as part of the nis "ttfields in germany in routine clinical care".On (b)(6) 2019, patient's spouse reported that patient was hospitalized on july 27, 2019 and that her resection scar required stitching due to adhesions (most recent resection surgery was (b)(6) 2019).Optune therapy was temporarily discontinued on (b)(6) 2019.Patient was discharged from hospital on (b)(6) 2019.On (b)(6) 2019, patient was hospitalized again due to purulent wound healing disorder (approximately 3cm length per medical record).That same day surgical wound revision was performed.Bone flap and underlying dura were covered with pus, thus bone flap was removed and dura was cleaned.The dura was still intact.Intracranial epidural abscess was removed.Antibiotic therapy with meropenem and vancomycin was initiated and changed to flucloxacillin and ciprofloxacin after wound cultures were positive for staphylococcus aureus and enterobacter cloacae.Post-operative course was without complications and patient was discharged home on (b)(6) 2019 with sutures already removed.Prescribing physician could not exclude a contribution of optune therapy to the event.

Manufacturer Narrative

Novocure is submitting a follow-up mdr to add contact information for the initial reporter in section e1.

Manufacturer Narrative

On (b)(6) 2021, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, INC.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 8940123
• MDR Text Key: 160753684
• Report Number: 3009453079-2019-00119
• 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,Followup,Followup
• Report Date: 01/07/2022

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: TFH9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 4 MO
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 06/25/2020; 12/23/2021
• Supplement Dates FDA Received: 07/22/2020; 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DALTEPARIN SODIUM; DEXAMETHASONE; LACOSAMIDE; LEVETIRACETAM; MIRTAZAPINE; PANTOPRAZOLE; PIRITRAMIDE; TEMOZOLOMIDE; TINZAPARIN SODIUM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 86 KG