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

Model Number NEUROSTAR 3.0

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

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 05/29/2022

Event Type  Injury  

Event Description

Healthcare professional reported that a patient with severe depression had attempted suicide after 8th treatment with tms.Patient was hospitalized and transferred to a psychiatric unit.

Manufacturer Narrative

Suicidal ideation is not an uncommon symptom of major depressive disorder.Additionally the patient is reported to be on bupropion which may cause some people to have suicidal thoughts and tendencies.Due to these confounding facts, it is impossible to determine the cause of the patient's condition.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814027
• MDR Report Key: 15138106
• MDR Text Key: 296957577
• Report Number: 3004824012-2022-00007
• Device Sequence Number: 1
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161519
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BUPROPION 150 MGPROZAC 60 MG
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Sex: Female