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

Model Number 10684331

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hearing Impairment (1881)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Siemens investigated the reported event and evaluated the reported system.As stated previously in, the system was found to be within specification.A save log of the examination was not found during the system evaluation.Siemens has requested additional information from the customer facility to determine if there was anything extraordinary about the examination and to obtain the protocols used for this case.A supplemental report will be submitted if additional information is received.

Event Description

It was initially reported to siemens that a patient complained of a "sudden deafness" after an mri examination with the magenetom avanto dot upgrade system on (b)(6) 2022.The patient reportedly informed the hospital of the deafness on (b)(6) 2022.The issue was not reported to siemens at that time.The event was reported to siemens on (b)(6) 2023 and additional information about the event to determine reportability was not received by siemens until (b)(6) 2023 and (b)(6) 2023.The additional information clarified that the patient underwent a brain scan for headaches, dizziness, and insomnia on (b)(6) 2022.Furthermore, it was clarified that hearing impairment and hypoacusis would be the more suitable terms for the patient's condition than initially reported term "sudden deafness".It was also confirmed that the patient had worn ear plugs and mri headphones during the scan in compliance with the instructions of the system operator manual and the complaint mri system is within specification.It is unclear if the patient has had any hearing issues before the scan.It was stated that there was no hearing impairment right after the mri scan on (b)(6) 2022.On the next day, (b)(6) 2022, the patient was at the hospital to discuss the results of the mri scan.The patient did not mention having any issues with their hearing on this date.Afterwards (date unknown), the patient consulted an ent physician (ear, nose, and throat) at another hospital for her hearing issue.It is unknown if the patient received medical treatment from the ent physician for this issue.On (b)(6) 2022, twelve days after the brain scan, the patient informed the hospital about their hearing issues for the first time.It was reported that by (b)(6) 2022, the patient's hearing had improved.As of the date of this report siemens cannot determine with absolute certainty that the hearing impairment is reversable.

Manufacturer Narrative

H10 manufacturer narrative/h11 corrected data regarding patient dates and mfr reporting number: siemens completed the investigation of the reported event.As previously reported, siemens was informed about an injury associated with this issue.It was stated that on 2022-11-14 a patient received an mri scan with a magnetom avanto dot, and that sudden deafness occurred after the scan.Further was stated that the patient informed the hospital on 2023-01-05 about this issue.We were informed that the patient wore ear plugs, and the mri headphones during the scan, which is in compliance with the instructions of the operator manual magnetom avanto, magnetom verio - operator manual.As per the additional information from 2023-01-12 and 2023-01-13 it was clarified that the patient had received a brain scan for their precondition of headaches, dizziness, and insomnia.Further it was clarified that the terms hearing impairment and hypoacusis would be the more suitable terms for the condition than the initially the used term "sudden deafness".Also, it was confirmed that the mri system is within specification.It is unclear if the patient has had any hearing issues before the scan.It was stated that there was no hearing impairment right after the mri scan.On the next day (2022-11-15) the patient was at the hospital to discuss the results of the mri scan.The patient did not mention having any issues with their hearing.After that meeting the patient consulted an ent doctor (ear, nose, and throat) at another hospital.It is unknown if the patient received medical treatment from the doctor of the other hospital for this issue.On 2022-11-26, twelve days after the brain scan, the patient informed the hospital about their hearing issues for the first time.It was stated that by 2022-12-19 the patient's hearing has improved.On 2023-03-02 we have received another update concerning the patient.It was stated that the patient has had an appointment with a ns doctor in february, but the patient did not but did not show up for that appointment.In summary no hardware or software problem was found, which would explain the hearing impairment.No similar incidents have been reported to us from the customer.The root cause for the hearing impairment could not be determined.Generally, the magnetom avanto dot can exceed acoustic noise levels higher than 99 db(a).This is the maximum noise level limit according to nema ms 4-2006 standard.Therefore, appropriate hearing protection needs to be provided to the patient.The operator manual and the magnetom avanto system owner manual provide instructions and warnings regarding noise levels and the respective hearing protection required and the importance of its proper use.The assessment of the reported incident does not indicate a system failure or malfunction and no non-conformity was identified.However, for patients with sensitive hearing, existing hearing issues or related preconditions, mr scans can be perceived as loud even with appropriate hearing protection.Nevertheless, hearing impairment can be caused by many different factors.The complaint was initially reported as mfr report number 3002808157-2023-59487, instead of the correct number which should have been 3002808157-2023-54760.The initial report was submitted on january 17, 2023.This supplemental report is being submitted with the same mfr report number as the initial to avoid confusion.

• Brand Name: MAGNETOM AVANTO DOT UPGRADE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 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: 16188234
• MDR Text Key: 307558949
• Report Number: 3002808157-2023-59487
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006628
• UDI-Public: 04056869006628
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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
• Device Operator: Health Professional
• Device Model Number: 10684331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG