MAGSTIM HORIZON 3.0 TMS THERAPY SYSTEM WITH STIMGUIDE+

Description of Event or Problem

USER FACILITY CONTACTED MAGSTIM ON (B)(6) 2025 TO INFORM THAT THE TECHNICIAN WHO HAS BEEN HELPING US TROUBLESHOOT SOFTWARE ISSUES, HE WAS CONNECTING THE COIL TO THE SYSTEM WHEN HE RECEIVED A SHOCK. TECHNICIAN WAS REPORTED DISORIENTATED AND WAS TAKEN TO THE ER TO BE EVALUATED. HOSPITAL DIRECTOR HAS ENSURED THE DEVICE IS UNPLUGGED AND TAGGED TO PREVENT ANY FURTHER USE.

Description of Event or Problem

USER FACILITY CONTACTED MAGSTIM ON (B)(6) 2025 TO INFORM THAT THE TECHNICIAN WHO HAS BEEN HELPING US TROUBLESHOOT SOFTWARE ISSUES, HE WAS CONNECTING THE COIL TO THE SYSTEM WHEN HE RECEIVED A SHOCK. TECHNICIAN WAS REPORTED DISORIENTATED AND WAS TAKEN TO THE ER TO BE EVALUATED. HOSPITAL DIRECTOR HAS ENSURED THE DEVICE IS UNPLUGGED AND TAGGED TO PREVENT ANY FURTHER USE. USER FACILITY RESPONDED TO COMMUNICATION (B)(6) 2025 AND STATED THAT INSPECTION OF THE MACHINE IDENTIFIED THAT THE MACHINE WAS PLUGGED IN BUT POWERED DOWN AT THE TIME A CRACKED PIECE ON A PLUG HAD ALREADY BEEN REPORTED TO MAGSTIM IN A SEPARATE OCCURRENCE. ALTHOUGH THE EMPLOYEE WAS SEEN IN THE ER, HE WAS NEVER ADMITTED TO THE HOSPITAL AND RETURNED TO WORK WITHOUT RESTRICTIONS, AFTER ONE WEEK OF REST.

Additional Manufacturer Narrative

THIS REPORT IS A FOLLOW-UP TO OUR INITIAL SUBMISSION CONCERNING THE REPORTED INCIDENT. A TECHNICAL REVIEW OF THE EVENT, BASED ON THE INFORMATION PROVIDED, AND A COMPREHENSIVE REVIEW OF THE DEVICE'S DESIGN AND SAFETY FEATURES WAS CONDUCTED. THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, DESPITE MULTIPLE FOLLOW-UP ATTEMPTS. OUR INVESTIGATION INDICATES THAT A DEVICE-RELATED MALFUNCTION IS UNLIKELY TO CAUSE THE REPORTED EVENT AS THE SYSTEM IS EQUIPPED WITH MULTIPLE LEVELS OF SAFETY FEATURES DESIGNED TO PREVENT ACCESS TO HIGH VOLTAGE UNDER ALL OPERATING CONDITIONS, IN ACCORDANCE WITH ISO 60601-1. BASED ON THE INFORMATION PROVIDED IN THE USER REPORT, THE INCIDENT OCCURRED WHILE THE USER WAS PLUGGING AND UNPLUGGING THE COIL DUE TO THE SYSTEM NOT RECOGNISING IT. IN THIS SCENARIO THE SYSTEM WOULD NOT BE IN AN ARMED STATE, THERE WOULD BE NO HIGH VOLTAGE IN THE SYSTEM, ALSO THE ABSENCE OF REPORTED SYSTEM ERRORS, CONFIRMS THAT THE DEVICE'S INTERNAL SAFETY SYSTEMS WERE OPERATING CORRECTLY. FURTHERMORE, THE HIGH VOLTAGE CONTACTS ON THE DEVICE ARE RECESSED SO THAT ACCESS TO THESE CONTACTS CANNOT BE ACHIEVED BY THE HUMAN HAND, CONTACT WOULD REQUIRE DELIBERATE INSERTION OF A CONDUCTIVE OBJECT. AN INTERNAL REVIEW OF MANUFACTURING DOCUMENTATION AND QUALITY INSPECTION RECORDS SHOW THE DEVICE LEFT THE FACILITY IN ACCORDANCE WITH QC RELEASE SPECIFICATIONS. A FULL INVESTIGATION TO DETERMINE THE ROOT CAUSE WAS UNABLE TO BE PERFORMED AS THE DEVICE HAS NOT BEEN RETURNED DESPITE FOUR REQUESTS. SHOULD THE DEVICE BE RETURNED, MAGSTIM WILL SUBMIT A SUPPLEMENTAL REPORT WITH THE INVESTIGATION RESULTS.