MAUDE Adverse Event Report: Siemens Healthineers AG MAGNETOM Symphony A Tim; System, Nuclear Magnetic Resonance Imaging

Catalog Number	10018223
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of a patient injury associated with a magnetom symphony, a tim system.It was stated after an mri (ankle) examination was completed, the patient complained that his tinnitus was now permanent as a result of the loud noise during the mr examination.Additional information regarding the patient's tinnitus has been requested by siemens healthineers, but no information has been received regarding the severity of the tinnitus and if it is still considered permanent as of the date of this report.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.

• Brand Name: MAGNETOM Symphony A Tim
• Common Device Name: System, Nuclear Magnetic Resonance Imaging
• Manufacturer (Section D): Siemens Healthineers AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer (Section G): Siemens Healthineers AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; +1(484)323-4198
• MDR Report Key: 50017610
• Report Number: 3002808157-2026-00018
• Device Sequence Number: 13133930
• Product Code: LNH
• UDI-Device Identifier: 04056869020471
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10018223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male