MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Itching Sensation (1943); Pain (1994); Skin Irritation (2076)

Event Date 08/20/2020

Event Type  Injury  

Event Description

Patient developed red, painful, hot and itchy area over the entire left side of the scalp (which is the side the magnetic coil sits during treatment).Neurostar for tms, start date: (b)(6) 2020.Fda safety report id # (b)(4).

• Brand Name: NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.
• MDR Report Key: 10459755
• MDR Text Key: 204759201
• Report Number: MW5096301
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR