NEUROSTAR

Additional Manufacturer Narrative

THE PERSON ALLEGING SERIOUS ADVERSE EVENTS ON THE MEDWATCH FORM DID NOT PROVIDE CONTACT INFORMATION AND THEREFORE NO ADDITIONAL INFORMATION COULD BE COLLECTED TO CONDUCT A THOROUGH INVESTIGATION. NEURONETICS WAS UNABLE TO CONFIRM THAT THE PERSON WAS TREATED WITH A NEUROSTAR DEVICE BUT IS SUBMITTING THIS MDR OUT OF AN ABUNDANCE OF CAUTION. AS A FURTHER NOTE, THIS ADVERSE EVENT IS SUBMITTED TO THE AGENCY LATE AS A CORRECTIVE ACTION SINCE IT WAS DETERMINED TO BE REPORTABLE AFTER AN AUDIT OF THE COMPANY'S COMPLAINT DATABASE.

Description of Event or Problem

NEURONETICS RECEIVED INFORMATION FROM MEDWATCH MW5090679 THAT A PATIENT EXPERIENCED HEARING LOSS, TINNITUS AND COGNITIVE IMPAIRMENT AFTER BEING TREATED WITH TMS.