MAUDE Adverse Event Report: THE MAGSTIM COMPANY LIMITED HORIZON; HORIZON PERFORMANCE

Catalog Number 5200-US

Device Problem Insufficient Information (3190)

Patient Problem Convulsion/Seizure (4406)

Event Date 06/25/2021

Event Type  Injury  

Event Description

The patient completed 29 sessions of approximately daily on weekday tms sessions.On the afternoon of the 29th session, six hours after the stimulation, the patient had a seizure.Full on-loss of consciousness, fell out of the chair, convulsed, bit tongue and the side of cheek, various scrapes and bumps.Rigid for a little bit, stopped answering to their name and hands began to shake.Patient recovering well although it's taken some time and they have been tired, headachy and sore.Sessions used 1,800 pulses of itbs to psts at 90% resting motor threshold.The patient had 52,200 pulses total.This is considered off-label use of horizon.

Event Description

The patient completed 29 sessions of approximately daily on weekday tms sessions.On the afternoon of the 29th session, six hours after the stimulation, the patient had a seizure.Full on-loss of consciousness, fell out of the chair, convulsed, bit tongue and the side of cheek, various scrapes and bumps.Rigid for a little bit, stopped answering to their name and hands began to shake.Patient recovering well although it's taken some time and they have been tired, headachy and sore.Sessions used 1,800 pulses of itbs to psts at 90% resting motor threshold.The patient had 52,200 pulses total.This is considered off-label use of horizon.

Manufacturer Narrative

Once the complaint was reported on the (b)(6) 2021, magstim reached out to the physicians on a number of occasions who provided the tms treatment to the patient but as of the (b)(6) 2021 the physicians have not responded about a teleconference to gather more information.As of (b)(6) 2021 a teleconference has still been unable to be arranged.On the (b)(6) 2021 a call was had with the nurse care coordinator and the clinic supervisor to discuss the sevents of what happened and any follow up information.On the (b)(6) 2021 a call was had with the nurse care coordinator and the clinic supervisor to discuss the events further and they informed us that the patient has had a conventional eeg and neurology exam, epilepsy protocol 3t mri which will be seen by dr walczak, the neurologist who examined her, and by dr.Alex rotenberg at boston childrens's hospital all with relatively normal results.Both dr walczak and ziad nahas md stated they believed that while it is not possible to prove either way that tms was or was not the cause of the seizure, with their experience and expertise they did not believe that tms was likely to have been the cause of the seizure primarily related to the 6 hour window between the end of the tms treatment and the seizure.The risk assesment for horizon (td 4960005) hazards leading too seizure are well documented.(hazards can be seen in haz id 3aa2, haz3 id aa3, haz id 3aa4, haz id 3aa18, haz id 3aa19, haz3ba3, haz id 3bd3, haz id 3bd4 and haz id 4aa2) as both dr walczak and ziad nahas md stated they believed that while it is not possible to prove either way that tms was or was not the cause of the seizure, with their experience and expertise they did not believe that tms was likely to have been the cause of the seizure in this instance.As such it is believed that the risk assessment still adequate.

• Brand Name: HORIZON
• Type of Device: HORIZON PERFORMANCE
• Manufacturer (Section D): THE MAGSTIM COMPANY LIMITED; spring gardens; whitland, carmarthenshire SA340 HR; UK SA340HR
• Manufacturer (Section G): THE MAGSTIM COMPANY LIMITED; spring gardens; whitland, carmarthenshire SA340 HR; UK SA340HR
• Manufacturer Contact: scott brown ; spring gardens; whitland, carmarthenshire SA340-HR ; UK SA340HR
• MDR Report Key: 12299309
• MDR Text Key: 265774315
• Report Number: 8021774-2021-00012
• Device Sequence Number: 1
• Product Code: QCI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: Health Professional
• Device Catalogue Number: 5200-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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
• Patient Outcome(s): Required Intervention