MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY; TRANSCRANIAL MAGNETIC STIMULATION

Model Number NEUROSTAR ADVANCED THERAPY V 3.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/03/2024

Event Type  Injury  

Event Description

Provider's office called neuronetics to report that their patient's mother is concerned that the patient (her son) has experienced a significant worsening in his ocd symptoms after receiving 16 treatments.The patient has reportedly been staying up "all night making lists and checking them over and over, not sleeping".

Manufacturer Narrative

Neuronetics received a call from a provider's office regarding a patient's mother that reported the patient had experienced a worsening in his ocd symptoms after receiving 16 treatments.Per the patient's mother, the patient had not been sleeping and had been "making lists" all night and checking them "over and over".The provider noted that the increase in the patient's symptoms have been a result of having to come into the office everyday to receive treatment which has disrupted his routine as his daily routine has been shifted to accommodate treatment.Patient received 4 more treatments (20 treatments total) before discontinuing tms.At the time of discontinuation, the patient reportedly began having "an increase in racing thoughts and issues with concentration in school" which was not present at the beginning of treatment.Since discontinuing tms, the patient reported that his ocd symptoms have gone back to how they were before tms but his therapist noted that the patient is still feeling emotionally disregulated following tms as he has exhibited an increase in checking and planning behaviors but this "may be due to external factors".The patient was being treated off-label for ocd as patient is not currently on any medications and is an adolescent.Neuronetics is reporting out of an abundance of caution as it is unclear as to what may have contributed to the patient's reported symptoms.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355 ; 6106404202
• MDR Report Key: 18836090
• MDR Text Key: 336866493
• Report Number: 3004824012-2024-00006
• Device Sequence Number: 1
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NEUROSTAR ADVANCED THERAPY V 3.6
• Device Catalogue Number: 81-03315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Race: White