MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM VIDA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 11060815

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

Patient Problems Tinnitus (2103); Partial Hearing Loss (4472)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event occurred following examination on the magnetom vida mr system.Initially it was stated that a patient underwent an mri on (b)(6) 2022.After some time had passed after the examination, the patient sent a letter to the hospital alleging that they partly lost hearing after the mri examination.The patient letter was dated (b)(6) 2022 and was processed internally at the hospital before siemens was made aware of this incident on (b)(6) 2022.It was further clarified that the patient previously had tinnitus in their left ear before the mri examination.After the mri examination, the patient observed tinnitus in both ears.The tinnitus increased to a 7/10 while the audition was decreased.During the examination the patient's hearing was protected with regular ear plugs as well as provided mini ear muffs.Padding was provided around the head to keep the head stable in the head coil and to reduce the noise as the headphones did not fit into the head coil.At this time it is unclear if the increased tinnitus in the left ear and the new tinnitus in the right ear is temporary or permanent.Siemens has requested additional information in order to conduct an investigation of the reported event.

Event Description

***additional information/clarification*** the patient already has had a tinnitus in the left ear (2/10) before the mri examination.After the mri examination the patient observed tinnitus in both ears.The patient reportedly followed-up with an ear specialist after the event.The patient reported that the tinnitus increased to 7/10 and hearing decreased.

Manufacturer Narrative

Siemens has completed the investigation of the reported event.Initially it was stated that a patient underwent an mr examination on 2022-01-21.The patient sent a letter to the hospital alleging that they partly lost their audition after the mri examination.The patient letter was dated 2022-02-24 and was processed internally at the hospital before siemens was made aware of this incident on 2022-03-07.Additional information stated that the patient already has had a tinnitus in the left ear (2/10) before the mri examination.After the mri examination the patient observed tinnitus in both ears.The patient reportedly followed-up with an ear specialist after the event.The patient reported that the tinnitus increased to 7/10 and while hearing decreased.Despite several requests, siemens was not able to obtain further information regarding the patient.It is unknown if the patient still having increased tinnitus in both ears and still suffering auditory deficiency.During the examination, the patient's hearing was protected in three ways.The patient was wearing regular ear plugs, was provided additional mini earmuffs, as well as padding around the head to keep the head stable in the head coil and to reduce the noise.It was stated that the duration of the examination was as expected for this type of examination.The mr system has been checked by a siemens customer service engineer (cse) and was found to be functioning within specification.Furthermore, no similar incidents have been reported to siemens from the customer.Generally, the magnetom vida can exceed acoustic noise levels higher than 99 db(a).This is the maximum noise level limit according to nema ms 4-2010 standard.Therefore, appropriate hearing protection needs to be provided to the patient.The magnetom vida/ vida fit, magnetom sola / sola fit operator manual (page 34) and the magnetom vida system owner manual (page 12) provide instructions and warnings regarding noise levels and the respective hearing protection required.Additional operator manual information is provided in the following: magnetom vida/ vida fit, magnetom sola / sola fit operator manual - mr system, syngo mr xa20 - print no.Mr-02601g.621.04.02.02.Magnetom vida - system owner manual -syngo mr xa20 - print no.M11-03002g.629.04.02.02.The investigation of the reported incident did not indicate a system failure or malfunction, and no non-conformities were identified.For patients with sensitive hearing and existing tinnitus problems, mr scans can be perceived as loud even with appropriate hearing protection.Furthermore, tinnitus can be caused by many different factors.The root cause for the increased tinnitus and auditory deficiency could not be determined based on the investigation results and the provided patient information.This complaint has been closed.Additional action by siemens is not deemed necessary.

• Brand Name: MAGNETOM VIDA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13791561
• MDR Text Key: 291240861
• Report Number: 3002808157-2022-19297
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: 04056869039176
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K220425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other