MAUDE Adverse Event Report: THE MAGSTIM COMPANY LIMITED MAGSTIM RAPID; RAPID² STIMULATOR

Model Number 3012-00

Device Problem Insufficient Information (3190)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

The incident was discovered online via a magstim employee under the following journal letter to editor reference: "epileptic seizure following high frequency repetitive transcranial magnetic stimulation for bipolar depression: a case report" in brain stimulation (https://doi.Org/10.1016/j.Brs.2022.05.010).The article was 16 december 2021, with 09 may 2022 as the date of publication.Date of magstim awareness isas described earlier in this report.The incident was not communicated to magstim or the relevant competent authority.Based on the information in the article, it was reported in (b)(6) a (b)(6)-year-old female with a 2-year history of bipolar disorder.The patient is described as in the depressive phase during tms treatment.Medication described for management of the patient's condition at the time of the event was a combination of lithium carbonate (900 mg/d), aripiprazole (7.5 mg/d), and sertraline (50 mg/d), supplemented by rtms treatment.The treatment was carried out using an unknown magstim device with a 70-mm figure eight coil placed over the left dorsolateral prefrontal cortex.Motor threshold was established and the patient was comfortably seated during the sessions when stimulations were delivered at 10 hz, 60 trains, train duration of 5.0 seconds, intertrain interval 15 seconds (ie, 3,000 pulses per session).On the fourth day of treatment the patient reported disrupted sleep with approximately 3 hours for the previous evening.Early into the session the operator first noted symptoms of eye turning, convulsed, lost consciousness and urinary incontinence during rtms treatment.The seizure lasted for about one minute, after which the symptoms gradually subsided.Supine position with given tongue depressor wrapped with gauze between the upper and lower teeth, oxygen inhalation, and intravenous injection of diazepam 5mg were performed immediately after the occurrence of seizure.In about ten minutes, the patient was moved to the ward for oxygen inhalation and ecg monitoring when the patient's muscles relaxed somewhat.The patient was awake after 1 hour.A day later the patient complained of numbness in the right tongue while no tongue biting or other physical trauma was observed and no abnormality was found in nervous system examination and cardiopulmonary auscultation.An eeg and a brain ct/mri were not done.There were not sequela.The patient was not retreated with tms.The clinical diagnosis of this event was tms related seizure.

Event Description

The incident was discovered online via a magstim employee under the following journal letter to editor reference: "epileptic seizure following high frequency repetitive transcranial magnetic stimulation for bipolar depression: a case report" in brain stimulation (https://doi.Org/10.1016/j.Brs.2022.05.010).The article was 16 december 2021, with 09 may 2022 as the date of publication.Date of magstim awareness isas described earlier in this report.The incident was not communicated to magstim or the relevant competent authority.Based on the information in the article, it was reported in china a 14-year-old female with a 2-year history of bipolar disorder.The patient is described as in the depressive phase during tms treatment.Medication described for management of the patient's condition at the time of the event was a combination of lithium carbonate (900 mg/d), aripiprazole (7.5 mg/d), and sertraline (50 mg/d), supplemented by rtms treatment.The treatment was carried out using an unknown magstim device with a 70-mm figure eight coil placed over the left dorsolateral prefrontal cortex.Motor threshold was established and the patient was comfortably seated during the sessions when stimulations were delivered at 10 hz, 60 trains, train duration of 5.0 seconds, intertrain interval 15 seconds (ie, 3,000 pulses per session).On the fourth day of treatment the patient reported disrupted sleep with approximately 3 hours for the previous evening.Early into the session the operator first noted symptoms of eye turning, convulsed, lost consciousness and urinary incontinence during rtms treatment.The seizure lasted for about one minute, after which the symptoms gradually subsided.Supine position with given tongue depressor wrapped with gauze between the upper and lower teeth, oxygen inhalation, and intravenous injection of diazepam 5mg were performed immediately after the occurrence of seizure.In about ten minutes, the patient was moved to the ward for oxygen inhalation and ecg monitoring when the patient's muscles relaxed somewhat.The patient was awake after 1 hour.A day later the patient complained of numbness in the right tongue while no tongue biting or other physical trauma was observed and no abnormality was found in nervous system examination and cardiopulmonary auscultation.An eeg and a brain ct/mri were not done.There were not sequela.The patient was not retreated with tms.The clinical diagnosis of this event was tms related seizure.

Manufacturer Narrative

Magstim is reporting a final reportable incident following investigation regarding this incident involving rapid device.On 28th june 2022, authorized chinese agent did a thorough interview with professor at the hospital where the incident took place.Contrary to what was previously stated by the chinese agent on 10th june 2022, the patient was indeed not treated with tms again, however, the patient did experience good mood improvement with no further seizure episodes.However, it was further identified that all three medications the patient was on (lithium carbonate (900 mg/d), aripiprazole (7.5 mg/d), and sertraline (50 mg/d)) are associated with increased risk of seizure events.Thus, using tricyclic antidepressants, neuroleptic agents and combination of being sleep deprived as in this patient's case, may have lead to lowering of the seizure threshold.The ifu (mop03-en revision 08 and mop03-cn revision 06) and the risk documentation for rapid has been reviewed with the potential risks and side effects of seizure events taking place having been documented.The rapid manual states that tms is contraindicated in individuals taking tricyclic antidepressants, neuroleptic agents or any other drug that could lower seizure threshold.Furthermore, the rapid manual states that tms in contraindicated in individuals suffering from sleep deprivation during rtms procedures.As such, hospital went against the recommendations and advice as specified by magstim company limited.Additionally, the hospital has used rapid device for an indication not approved in the labeling, as treatment of depression with rapid device has not been cleared in china - hence having led to off-label usage.Therefore, it has been deemed that the root-cause of this reportable incident was linked to ''user error'' due to the off-label usage of the product along with combination of medications which are contraindicated for use when undergoing transcranial magnetic stimulation.

Event Description

The incident was discovered online via a magstim employee under the following journal letter to editor reference: "epileptic seizure following high frequency repetitive transcranial magnetic stimulation for bipolar depression: a case report" in brain stimulation (https://doi.Org/10.1016/j.Brs.2022.05.010).The article was 16 december 2021, with 09 may 2022 as the date of publication.Date of magstim awareness isas described earlier in this report.The incident was not communicated to magstim or the relevant competent authority.Based on the information in the article, it was reported in china a 14-year-old female with a 2-year history of bipolar disorder.The patient is described as in the depressive phase during tms treatment.Medication described for management of the patient's condition at the time of the event was a combination of lithium carbonate (900 mg/d), aripiprazole (7.5 mg/d), and sertraline (50 mg/d), supplemented by rtms treatment.The treatment was carried out using an unknown magstim device with a 70-mm figure eight coil placed over the left dorsolateral prefrontal cortex.Motor threshold was established and the patient was comfortably seated during the sessions when stimulations were delivered at 10 hz, 60 trains, train duration of 5.0 seconds, intertrain interval 15 seconds (ie, 3,000 pulses per session).On the fourth day of treatment the patient reported disrupted sleep with approximately 3 hours for the previous evening.Early into the session the operator first noted symptoms of eye turning, convulsed, lost consciousness and urinary incontinence during rtms treatment.The seizure lasted for about one minute, after which the symptoms gradually subsided.Supine position with given tongue depressor wrapped with gauze between the upper and lower teeth, oxygen inhalation, and intravenous injection of diazepam 5mg were performed immediately after the occurrence of seizure.In about ten minutes, the patient was moved to the ward for oxygen inhalation and ecg monitoring when the patient's muscles relaxed somewhat.The patient was awake after 1 hour.A day later the patient complained of numbness in the right tongue while no tongue biting or other physical trauma was observed and no abnormality was found in nervous system examination and cardiopulmonary auscultation.An eeg and a brain ct/mri were not done.There were not sequela.The patient was not retreated with tms.The clinical diagnosis of this event was tms related seizure.

Manufacturer Narrative

A magstim employee discovered the report in a publicized paper "epileptic seizure following high frequency repetitive transcranial magnetic stimulation for bipolar depression: a case report" by xiaofang xu.This was not reported to magstim by the user.Magstim are submitting this follow up report as a cautionary response to ensure vigilance timelines are adhered to whilst allowing time for a full investigation to identify root cause.On 9 june 2022, magstim heard back from the chinese authorised agent (billion link) and it was agreed between both parties to set up a call on 10 june 2022 at 10:30 am (bst).During the call, the accident was discussed and further information was obtained from the chinese authorized agent regarding this event which was not included prior in the case study.Chinese authorized agent was able to obtain further information regarding the event, patient and the device used from the authors of this paper based in zhejiang university school of medicine (department of psychiatry ward, the first affiliated hospital).Billion link was told by the university that patient was taking medication as stated previously in the report, that can increase seizure risk by 40-45%.Contrary to the article, patient continued to have tms treatments done with 100% intensity to treat her bipolar disorder with reported successful treatment outcomes that have improved her bipolar disorder.Furthermore, the corresponding author did not report to billion link but had already reported to nmpa.It was also reported that the author was not aware that they were supposed to notify magstim.During the call, all required obligations of the chinese agent were discussed confirming that the appointed chinese agent in china is to facilitate reporting to the nmpa.Billion link has confirmed that they will get back with further information regarding reporting in china and with further details regarding the case if able to obtain further information from the authors of the study.Follow up emails have been sent since to billion link on 14-06-2022 and 17-06-2022 with no response.

• Brand Name: MAGSTIM RAPID
• Type of Device: RAPID² STIMULATOR
• 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: 14547575
• MDR Text Key: 292974348
• Report Number: 8021774-2022-00001
• Device Sequence Number: 1
• Product Code: QCI
• Combination Product (y/n): N
• PMA/PMN Number: K162935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

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 Model Number: 3012-00
• Device Catalogue Number: 3012-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 05/27/2022
• Supplement Dates FDA Received: 07/07/2022; 07/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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): Other
• Patient Age: 14 YR
• Patient Sex: Female