HORIZON

Additional Manufacturer Narrative

REGARDING THIS INCIDENT, THE MAPPING COIL WAS RIGHT ON TARGET AND AT THE 45-DEGREE ANGLE, THE PRACTITIONER ACTUALLY HAD A GREAT RESPONSE WITH ALL 4 PULSES GIVEN. IN HER OPINION THIS WAS A SYNCOPAL EPISODE IN WHICH IT SOMETIMES HAVE SEIZURE-LIKE ACTIVITY, A PSEUDO SEIZURE. THE SECOND EPISODE THE PATIENT HAD, APPROXIMATELY 4 MINUTES AFTER THE INITIAL EPISODE, WAS NOT PRECEDED BY ANY PULSE ACTIVITY. HE ALSO DIDN'T EXPERIENCE A POST ICTAL PERIOD WHICH FOLLOWS TRUE SEIZURES. AFTER THE FACT HE REPORTED THAT HE HAS PREVIOUSLY EXPERIENCED THESE EPISODES IN HEALTH CARE SETTINGS MAKING THE PRACTITIONER QUESTION IF IT IS ANXIETY DRIVEN. IT IS USUALLY DURING A BLOOD DRAW OR VACCINATION THAT THE PATIENT HAS HAD THIS HAPPEN. THE PATIENT WAS TAKEN TO THE ER WHERE THEY MONITORED HIM, NO TREATMENT WAS NEEDED, HE WAS RELEASED AND IS DOING WELL. CURRENT MEDICATION INCLUDES SERTRALINE, ABILIFY AND DEXTROAMPHETAMINE-AMPHETAMINE. THE TMS TREATMENT FOR THIS PATIENT WILL BE DISCONTINUED. THIS EVENT OCCURED AFTER 4 PULSES OF THE MAPPING COIL, MAKING THE PRACTITIONER UNCOMFORTABLE TO CONTINUE, EVEN THOUGH IT WAS NOT DUE TO THE MAGNETIC STIMULATION ITSELF. THE PATIENT WORKS THE EVENING SHIFT AND HAS A DIFFERENT SLEEP SCHEDULE THAN MOST BUT HASN'T HAD ANY CHANGES IN PATTERN. HE ALSO STATED BEING ANXIOUS ABOUT THE TREATMENT, AS THIS WAS HIS FIRST TIME, AND HE DID ADMIT HE WAS AFRAID OF THE UNKNOWN. UPON REVIEW OF THE RISK MANAGEMENT REPORT, THIS SIDE EFFECT IS CONSISTENT WITH THE CURRENT RISK AND DOES NOT INDICATE ANY NEGATIVE CHANGE IN RISK PROFILE. THE MANUFACTURER AGREES ON THE OPINION OF PRACTITIONER THAT IT WAS SYNCOPE WHICH IS A KNOWN POSSIBLE SIDE EFFECT OF RTMS AS INDICATED IN THE RISK MANAGEMENT AND MAY NOT BE CAUSED BY THE TMS DEVICE. UNDER ANY TYPE OF TMS STIMULATION IT IS POSSIBLE THAT A SYNCOPE CAN OCCUR AS AN EPIPHENOMENON - A SECONDARY EFFECT OF BY-PRODUCT OF BRAIN ACTIVITY - WHICH COINCIDES WITH THE POSSIBLE ANXIETY THE PATIENT WAS FEELING PRIOR TO TREATMENT AS WELL AS PREVIOUS EPISODES IN THE PAST RELATED TO POTENTIAL HIGH ANXIETY SITUATION LIKE NEEDLE INSERTION/ INJECTION. IT WON'T CHANGE THE RISK PROFILE OR ANY RISK SCORING. BASED ON RESPONSE FROM THE PRACTITIONER AND THE REVIEW OF RISK MANAGEMENT REPORT, IT CAN BE CONCLUDED THAT THE CAUSE OF INCIDENT IS NOT RELATED TO THE DEVICE.

Description of Event or Problem

ON 15 OCT 2024, MAGSTIM HAS BEEN CONTACTED BY PRACTITIONER REGARDING AN INJURY: A SEIZURE TYPE OF ACTIVITY WAS NOTED AFTER 4 PULSES OF THE MAPPING COIL, THE FIRST TWO PULSES WERE GIVEN AT 65, THE SECOND TWO AT 58. AFTER THE 4TH PULSE HE PASSED OUT AND STARTED TENSING IN SEIZURE TYPE OF ACTIVITY AND BECAME VERY DIAPHORETIC. THE EPISODE LASTED ABOUT 5 SECONDS. AS SOON AS HE REGAINED CONSCIOUSNESS, HE WAS ALERT AND ORIENTED. ABOUT 4 MINUTES LATER HE PASSED OUT AGAIN AND EXPERIENCED THE SAME SEIZURE TYPE OF ACTIVITY. HIS VITAL SIGNS REMAINED WITHIN DEFINED LIMITS AS WAS HIS OXYGEN LEVEL. EMS WERE CONTACTED AND HE WAS TAKEN TO THE AMBULANCE. HE STATES THIS HAS HAPPENED PREVIOUSLY DURING BLOOD DRAW OR INJECTIONS. MAPPING WAS DISCONTINUED AS SOON AS HE PASSED OUT, WHICH AGAIN, WAS AFTER 4 PULSES WERE GIVEN.

Additional Manufacturer Narrative

COMPLAINT AND INCIDENT HAVE BEEN LOGGED WITHIN THE MANUFACTURER'S QMS TO FACILITATE THE INTERNAL INVESTIGATION PROCESS. CLINIC HAS BEEN CONTACTED ON THE 15TH OF OCTOBER FOR ADDITIONAL DETAILS INTO THE INCIDENT. INVESTIGATION OF THE INCIDENT IS IN PROGRESS TO DETERMINE ROOT CAUSE.

Description of Event or Problem

ON (B)(6) 2024 MAGSTIM HAS BEEN CONTACTED BY PRACTITIONER REGARDING AN INJURY: A SEIZURE TYPE OF ACTIVITY WAS NOTED AFTER 4 PULSES OF THE MAPPING COIL, THE FIRST TWO PULSES WERE GIVEN AT 65, THE SECOND TWO AT 58. AFTER THE 4TH PULSE HE PASSED OUT AND STARTED TENSING IN SEIZURE TYPE OF ACTIVITY AND BECAME VERY DIAPHORETIC. THE EPISODE LASTED ABOUT 5 SECONDS. AS SOON AS HE REGAINED CONSCIOUSNESS, HE WAS ALERT AND ORIENTED. ABOUT 4 MINUTES LATER HE PASSED OUT AGAIN AND EXPERIENCED THE SAME SEIZURE TYPE OF ACTIVITY. HIS VITAL SIGNS REMAINED WITHIN DEFINED LIMITS AS WAS HIS OXYGEN LEVEL. EMS WERE CONTACTED AND HE WAS TAKEN TO THE AMBULANCE. HE STATES THIS HAS HAPPENED PREVIOUSLY DURING BLOOD DRAW OR INJECTIONS. MAPPING WAS DISCONTINUED AS SOON AS HE PASSED OUT, WHICH AGAIN, WAS AFTER 4 PULSES WERE GIVEN.