NEURONETICS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-24 for NEURONETICS manufactured by Neuronetics.

Event Text Entries

[18113477] After doing research - i realize the product used on my mother was being used off-label, and caused serious problem. My mother suffers from major depression. The research i found shows this device is approved for patients that have failed just one drug test of adequate dose and duration. My mother had failed 4 just in the last 4 months and was scheduled for ect. Instead she was pushed to tms - neuronetics - got worse, became suicidal and had to be admitted as an inpatient. There is no way she would have been sent to tms except for the doctors greed. I called around and no one is using the product one label using it for ptsd, right sided, different settings, bi-polar disease, etc. This company needs to be stopped before they make someone commit suicide because they arer not using their product for on-label use. I'm not even sure if this is the correct site to report the marketing of off-label use of the device... As i said i called 20 centers all are marketing it off label.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5013195
• MDR Report Key: 1517760
• Date Received: 2009-10-24
• Date of Report: 2009-10-24
• Date of Event: 2009-10-02
• Date Added to Maude: 2009-11-02
• 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: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEURONETICS
• Generic Name: NEURONETICS
• Product Code: OBP
• Date Received: 2009-10-24
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEURONETICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2009-10-24