MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 09/27/2015

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with prescribing physician that the fall was not related to optune therapy.However, the associated laceration was related to optune use.Falls were reported on the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (7% and 2% in optune/tmz and tmz arms respectively).

Event Description

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015 novocure was informed that on (b)(6) 2015 the patient was hospitalized due to a fall and required sutures for a head wound sustained from mechanical impact with an optune array disk.It was unknown if there was loss of consciousness or seizure activity associated with the fall.The patient was experiencing disease progression at the time of the event.Per prescribing physician, the fall was not related to optune therapy.

• 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: 5210679
• MDR Text Key: 30725959
• Report Number: 3009453079-2015-00063
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• 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
• Report Date: 10/09/2015

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-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 3 YR
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2012
• 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: CO-PHENOTROPE
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR