MAUDE Adverse Event Report: BRAINSWAY LTD BRAINSWAY DEEP TMS SYSTEM (H1 COIL); TRANSCRANIAL MAGNETIC STIMULATOR

Model Number HEL-260215004-3

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

Patient Problems Hemorrhage/Bleeding (1888); Seizures (2063); Vomiting (2144); Injury (2348)

Event Date 04/23/2018

Event Type  Injury  

Event Description

The patient was as (b)(6) married white female with a 20+ year history of depression and anxiety, previously tried on multiple antidepressants.She was receiving tms for the treatment of resistant depression using the brainsway hi coli.During treatment #11, she experienced a generalized seizure, including tongue biting with bleeding, vomiting, and post-ictal confusion.She was taken to the emergency room (er) for evaluation and the released.The patient wanted to continue treatment (b)(6) 2018, we started the brainsway treatment again.The patient was unable to complete a full course of tms despite having a seizure with no additional complications, no changes to the eeg, and with clinical improvement.

• Brand Name: BRAINSWAY DEEP TMS SYSTEM (H1 COIL)
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD; jerusalem 91451 ; IS 91451
• MDR Report Key: 7909977
• MDR Text Key: 121991501
• Report Number: MW5080096
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEL-260215004-3
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 50 YR
• Patient Weight: 59