MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution to the event cannot be excluded.Contributing factors for wound dehiscence in this patient include: concomitant carmustine (carries a warning for impaired neurosurgical wound healing.Source: carmustine 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 dehiscence 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.).

Event Description

A (b)(6)-year-old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019, as part of the nis "ttfields in (b)(6) in routine clinical care".On (b)(6) 2019, novocure was informed by the son that during the transducer array exchange on (b)(6) 2019, a liquid filled blister was found on the scalp near the surgical resection scar site (last resection (b)(6) 2019).On (b)(6) 2019, patient presented to the emergency department with a worsening of scalp condition.Upon arrival, patient reported the wound area had been swollen with clear liquid drainage.Patient was admitted and optune therapy was temporarily discontinued.Patient had no fever, no malaise, no headache, no dizziness and no nausea.Cranial mri was stable without evidence of an abscess.Lumbar drain was placed and subsequently removed on (b)(6) 2019.During the hospital stay, no further wound drainage or swelling was observed.There was no report of surgical repair for the wound.On (b)(6) 2019, patient was discharged home.Prescriber stated a possible cause of the event was due to the adhesion from the transducer array placement within the surgical resection area.

Manufacturer Narrative

On december 23, 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 GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• 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: 9262093
• MDR Text Key: 179112974
• Report Number: 3009453079-2019-00126
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• 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: 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
• Device Age: 30 MO
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: CARMUSTINE.; DEXAMETHASONE.; ENOXAPARIN SODIUM.; IBUPROFEN.; INSULIN GLARGINE.; LACOSAMIDE.; LEVETIRACETAM.; ONDANSETRON.; PANTOPRAZOLE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG