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

Model Number	11410481
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an incident occurred after a patient examination with the magnetom vida fit system on (b)(6), 2022.On (b)(6), 2022, additional information was received by siemens regarding the incident and based on this information it was determined the complaint was reportable.Per the complaint report there was a serious injury associated with this issue.It was stated that a patient with ear epithesis pins was examined with a 3 t mri.Afterwards the epithesis pins in the patient's ears were no longer magnetic.To replace the epithesis pins a surgical procedure is necessary.The patient has had previous examinations with 3 t mri systems during which the epithesis pins were not affected.Although the relation between the last mri examination and the loss of magnetism of the patient's ear epithesis pins is unclear, siemens decided to report this incident with an abundance of caution.The reported event occurred in germany.
Additional Manufacturer Narrative
Siemens has initiated an investigation of the reported event.The root cause has not yet been determined.Siemens will submit a supplemental report if additional reportable information available.Internal id# (b)(4).
Additional Manufacturer Narrative
H10 manufacturer narrative: siemens completed the investigation for the reported event.Additional information was received from the customer stating that the patient's epithesis pins were not mr safe or conditional.The implants (pins) are made of surgical steel with a white iron magnet and chrome-plated screws.As previously reported, the patient had to undergo surgery to replace the demagnetized pins.The system worked as specified and the issue was caused by a user error.The operator manual explains in detail the potential hazards for patients due to a strong magnetic field and that only mr safe or mr conditional accessories, tools and devices are to be used within the specified and clearly marked areas.Additional action by siemens is not necessary.This complaint has been closed.H11 corrected data: the initial report number should have been 3002808157-2022-48711 not 3002808157-2022--49711.Since the initial report was named 3002808157-2022--49711, this supplemental report was submitted under the same report number for fda reporting consistency.This note has been added for siemens' documentation purposes regarding the report number for clarification.The report number should have corresponded with the internal siemens complaint number pm00348711.This error has no impact to the initial reporting of the event to the fda or the supplemental report.
Additional Manufacturer Narrative
It is not known if the patient underwent surgery to replace the demagnetized pins.It is only known to siemens that the patient will have to undergo surgery to replace the pins.

• Brand Name: MAGNETOM VIDA FIT
• Common Device Name: 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: 15657330
• Report Number: 3002808157-2022-49711
• Device Sequence Number: 6377193
• Product Code: LNH
• UDI-Device Identifier: 04056869245188
• UDI-Public: 04056869245188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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 Model Number: 11410481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 12/08/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/07/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown