MAUDE Adverse Event Report: MAGVENTURE A/S MAGVENTURE TMS; TRANSCRANIAL MAGNETIC STIMULATOR

Patient Problems Electrolyte Imbalance (2196); Convulsion/Seizure (4406)

Event Date 09/13/2023

Event Type  Injury  

Event Description

Pt had seizure like activity while undergoing tms.She was found to have significant and multiple metabolic abnormalities in the hospital some of which include potassium and magnesium which had to be corrected.Her ct scan and mri were negative.

• Brand Name: MAGVENTURE TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): MAGVENTURE A/S
• MDR Report Key: 17836576
• MDR Text Key: 324659561
• Report Number: MW5146262
• 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: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic