MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH Bonebridge; BCI Bone Conduction Implant

Model Number	BCI602 Bone Conduction Implant
Medical Device Problem Codes	No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the scan, he experienced severe pain on the left side of the head but did not interrupt the examination.After leaving the mri room, the user reported feeling as if they had been punched in the region of the left ear.Upon arriving home, the user placed the audio processor and noticed no hearing perception on the left side.When using the processor on the right side, hearing was perceived normally.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
During the scan, he experienced severe pain on the left side of the head but did not interrupt the examination.After leaving the mri room, the user reported feeling as if they had been punched in the region of the left ear.Device remains implanted.
Additional Manufacturer Narrative
Based on the received information from the field, the recipient experienced pain during an mri examination; however, continued the examination procedure.In addition, it was reported that the hearing benefit decreased after the mri procedure, but no explantation can be given for that, since the device is reportedly functioning based on carried out in situ testing.The device remains implanted and in use.This is a final report.

• Brand Name: Bonebridge
• Common Device Name: BCI Bone Conduction Implant
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; +43()577885626
• MDR Report Key: 25664350
• Report Number: 9710014-2026-00597
• Device Sequence Number: 17583731
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• UDI-Public: (01)09008737524838
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K191457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: Lay User/Patient
• Device Expiration Date: 06/22/2023
• Device Model Number: BCI602 Bone Conduction Implant
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 06/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male