Model Number NeuroStar 3.0 US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Skin Discoloration (2074); Tinnitus (2103); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Eye / Vision Problem (4471)
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Event Date 06/01/2018 |
Event Type
Injury
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Event Description
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Neuronetics, inc.Received a patient self-reported medwatch form (mw5108910) from fda on 05/03/2022.The patient alleges long-term side effects from three (3) tms treatments he had in 2018.The patient reported prolonged headache and skin discoloration at the treatment site following treatment.He also reported tinnitus and light sensitivity that has persisted for almost four (years).The patient acknowledged that he did not use hearing protection but used personal ear buds.
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Manufacturer Narrative
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Neuronetics was able to speak with the patient and the tms provider for additional information.Patient received a mapping session and 3 treatments only with neurostar tms.The treating physician confirmed that the "darkened skin" was due to marking the patient's head with a marker.He also did not think the patient's other symptoms were related to tms since he only had 3 treatments and they never got above 50% of 0.81% of the motor threshold.The physician had recommended the patient get an mri but the patient had not followed through.
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Search Alerts/Recalls
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