MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SOLA FIT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 11410482

Device Problem Use of Device Problem (1670)

Patient Problem Hearing Impairment (1881)

Event Date 08/20/2022

Event Type  Injury  

Event Description

The patient who had preexisting tinnitus before the mri examination on (b)(6) 2022, stated the tinnitus became worse after the examination performed using the magnetom sola fit system.The patient was wearing headphones only.Ear plugs were not worn in addition to the headphones for hearing protection during the procedure.The patient informed the hospital of the issue via email on may 9, 2023.

Manufacturer Narrative

E1: reporting facility contact telephone number is (b)(6).H3, h6: siemens has initiated an investigation of the reported event.Siemens will perform the investigation considering the complaint description and a review of the system history.Siemens advised the customer regarding the importance of using both headphones and earplugs for hearing protection for patients undergoing examination.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.

Manufacturer Narrative

H3, h6: siemens healthineers has completed the investigation of the reported event.It was initially communicated to siemens healthineers that there is a serious injury associated with a magnetom sola fit system (serial no.(b)(6).In the initial complaint report from 2023 (b)(6) it was stated that a patient, who has had a tinnitus before an mri examination, complained that the tinnitus worsened after the mri examination.The examination is stated to have taken place on 2022 (b)(6).The patient informed the hospital about this incident on 2023 (b)(6) via email, which is more than eight months after the mri examination took place.In the complaint report it was initially not specified if the worsening of the tinnitus was temporary or permanent.On 2023 (b)(6) and 2024 (b)(6) siemens healthineers received additional information which clarified some details concerning the incident.We were informed that the worsening of the patient¿s tinnitus is permanent.Siemens healthineers did not receive any information if the worsening of the tinnitus was diagnosed and confirmed by a medical professional and if the patient was medically treated.It was also stated that the patient was only wearing the mri headphones without any additional hearing protection, and it was specified that it was the standard siemens healthineers headphones which are provided with the system.As per the customers recollection the patient might have complained about the noise right after the examination.The patient expressed this in her email on 2023 (b)(6)to the hospital.The customer is unaware of anything unusual about the concerned examination.Hence, no data was collected to be investigated and no complaint submitted.As per the additional information there is no save log available.We have also requested dicom images of the concerned examination for an investigation.We were provided two different sets of dicom images which were investigated by an expert.He determined that one of the dicom image sets was from a magnetom solafit system.However, the dicom images are from an examination from 2023 (b)(6), while the event happened on 2022-08-20.The provided screen shot of the used protocols match the first set of dicom images and are therefore also not related to the incident in question.The other set of dicom images are from a magentom aera system and hence, aren¿t related to the incident in question as well.Consequently, any details about the examination remain unclear and we are unable to perform an investigation of the incident due to the lack of data.The system was checked by the customer service engineer (cse) during maintenance activities on 2023 (b)(6) and was found to be in specification.There are no further incidents of this system in the complaint data base.In summary no hardware or software problem was found, which would explain a worsening of a preexisting tinnitus.Therefore, the root cause for the worsening of the tinnitus is undetermined.

• Brand Name: MAGNETOM SOLA FIT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; 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., mc 65-1a; malvern, PA 19355 ; 8483234198
• MDR Report Key: 17098106
• MDR Text Key: 316874602
• Report Number: 3002808157-2023-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K221733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11410482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability