MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescriber that optune therapy was a contributing factor to the fall and hip fracture.Fall 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 (8% and 3% in optune/tmz and tmz arms respectively).Hip fracture 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 the tmz arm of the trial (<1%) only.

Event Description

An (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019.On (b)(6) 2019, novocure was informed by the patient's daughter that the patient tripped over the optune wires and fell and broke her hip.Per prescriber, the patient presented to the emergency room on (b)(6) 2019, after she tripped over the optune device wires.Patient experienced dizziness prior to the fall; however, no seizure activity or loss of consciousness was reported.Patient was admitted and optune therapy was temporarily discontinued.A left hip x-ray demonstrated a nondisplaced mildly impacted fracture that involved the subcapital capital portion of the left femoral neck.On (b)(6) 2019, pre operative ct redemonstrated femoral neck fracture with no osseous erosion, dislocation or evidence of soft tissue injury.Labwork was within normal ranges.Patient underwent a closed reduction and percutaneous pinning of the left hip.Patient started on a 4 week aspirin regimen (325 mg) for dvt prophylaxis and an unspecified pain medication.Patient was discharged to an acute rehabiliation facility for further care on (b)(6) 2019.Per prescribing physician, fall was due to dizziness and patient tripping over optune wires.

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: 9432541
• MDR Text Key: 185752222
• Report Number: 3009453079-2019-00130
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 3 YR
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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: ACETAMINOPHEN.; DEXAMETHASONE.; ESCITALOPRAM OXALATE.; LEVETIRACETAM.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White