UNKNOWN

Additional Manufacturer Narrative

THE EFFECTS OF TMS TREATMENT CLAIMED BY A PATIENT WERE ALREADY KNOWN SIDE EFFECTS AND WERE LISTED IN THE USER MANUAL FOR CLOUDTMS SYSTEM (PAGES 13-14). THIS IS THE ONLY DEVICE CLEARED BY NEUROSOFT FOR THE TREATMENT OF MAJOR DEPRESSION DISORDER IN THE USA. THE HEARING LOSS PROBLEM WAS FOLLOWED ALSO BY THE SUGGESTION THAT "ALL INDIVIDUALS WHO COMPLAIN OF HEARING LOSS OR TINNITUS SHOULD BE REFERRED FOR AUDIOMETRIC ASSESSMENT". AS FAR AS THESE EVENTS ARE KNOWN, DOCUMENTED SIDE EFFECTS, NEUROSOFT DECIDED THAT IT IS NOT A REPORTABLE EVENT. SINCE WE DO NOT HAVE ANY INFORMATION ABOUT THE PATIENT OR THE CLINIC WHERE THIS IS OCCURRED, WE ARE UNABLE TO FOLLOW ON THIS INCIDENT.

Description of Event or Problem

CALLER STATED THAT SHE HAD 36 SESSIONS OF TRANSCRANIAL MAGNETIC STIMULATOR (TMS) TREATMENT FOR DEPRESSION FROM (B)(6) 2023 TO (B)(6) 2023. SHE SAID THE TREATMENT HAS RUINED HER LIFE AND MANY OTHER PEOPLE. AFTER THE TREATMENT SHE EXPERIENCED SIGNIFICANT HEARING LOSS AND A STATE OF UNBELIEVABLE ANXIETY. SHE IS CURRENTLY IN AN UNDESIREABLE STATE OF ANXIETY. SHE FURTHER STATED THAT THE INDUSTRY IS LUCRATIVE BY DECEIVING THE CONSUMERS AND BENEFITING FROM THEM.