TMS NEUROSTAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for TMS NEUROSTAR manufactured by Neuronetics Inc..

Event Text Entries

[50236754] My son (b)(6) was approved for tms treatment through his psychiatrist, after 8-10 sessions he started feeling worse, more depression, more anxiety, more irritable, they said this could happen (only after he started treatment did they say this could happen, no mention before) he continued treatment and continued to get worse. He stopped tms at 18 sessions as the insurance would no longer approve payment since he was getting worse. My concern is that it was not disclosed that it could negatively impact his depression and i see others have experienced the same outcome. Neurostar is the maker of the tms device and i have reached out to them as well to report the feedback. I feel further testing/investigation may be needed before using this device on people already in a fragile state with depression, only to make it worse. My son wants to die and we both truly feel we would not have done the treatment if we would have known this was the outcome or there was even a chance it could make things worse.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063555
• MDR Report Key: 5811741
• Date Received: 2016-07-18
• Date Added to Maude: 2016-07-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TMS NEUROSTAR
• Generic Name: TMS NEUROSTAR
• Product Code: OBP
• Date Received: 2016-07-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEURONETICS INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-18