MAUDE Adverse Event Report: NOVOCURE OPTUNE; STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT

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

Patient Problems Fatigue (1849); Twitching (2172); Shaking/Tremors (2515); No Code Available (3191)

Event Date 12/25/2016

Event Type  Injury  

Event Description

The reporter states that the patient began using the product on (b)(6) 2016 in order to treat his glioblastoma condition.The reporter states that on (b)(6), the patient began experiencing side effects such as extreme fatigue, muscle twitching, hand tremors, and increased difficulty of staying focused.The reporter states that the patient has discontinued use of the device.

• Brand Name: OPTUNE
• Type of Device: STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT
• Manufacturer (Section D): NOVOCURE
• MDR Report Key: 6278905
• MDR Text Key: 65914763
• Report Number: MW5067447
• Device Sequence Number: 1
• Product Code: NZK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/25/2017

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DECADRON; KEPPRA; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 75