MAUDE Adverse Event Report: THE MAGSTIM COMPANY LTD. HORIZON TMS THERAPY SYSTEM

Catalog Number 4950-00

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/03/2022

Event Type  Death  

Event Description

Magstim ltd was informed by a user at the (b)(6) vamc that a patient who had been receiving treatment from them had taken their own life.The patient is known to suffer with major depressive disorder, comorbid ptsd and borderline personality disorder.The patient was towards the end of their theta burst treatment course of tms using magstim devices, as such magstim are submitting this initial report as a cautionary response to ensure vigilance timelines are adhered to whilst allowing time for a full investigation to identify the root cause.

Manufacturer Narrative

From the review of the horizon device manufacture control sheets, there were no deviations throughout device production or procedures.The device passed all manufacture inspection and release checks - as such there were no problems with the device identified.There have been no previous reports of any unexpected or similar incidents with the device.Investigation identified that the patient suffered from mdd, comorbid with ptsd and borderline pd.These conditions are known to place a patient at an increased risk of suicide.As there were no issues noted within the device's manufacture or use, and considering the patient's diagnosis, it may be accepted that the incident is not attributable to the device.

Event Description

Magstim ltd was informed by a user at the (b)(6) that a patient who had been receiving treatment from them had taken their own life.The patient is known to suffer with major depressive disorder, comorbid ptsd and borderline personality disorder.The patient was towards the end of their theta burst treatment course of tms using magstim devices, as such magstim are submitting this initial report as a cautionary response to ensure vigilance timelines are adhered to whilst allowing time for a full investigation to identify the root cause.

• Brand Name: HORIZON TMS THERAPY SYSTEM
• Type of Device: HORIZON TMS THERAPY SYSTEM
• Manufacturer (Section D): THE MAGSTIM COMPANY LTD.; spring gardens; whitland; swansea, ; UK
• Manufacturer Contact: scott brown ; spring gardens; camarthen, ; UK
• MDR Report Key: 14734386
• MDR Text Key: 294281094
• Report Number: 3011755356-2022-00002
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K182853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 4950-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• 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): Death