MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
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
The user came in to upgrade the audio processor (ap) after his previous ap broke.The user has not been able to hear any sound since that time.
Event or Problem Description
The user came in to upgrade the audio processor (ap) after his previous ap broke.The user has not been able to hear any sound since that time.
Additional Manufacturer Narrative
Based on the available information from the field, a technical implant failure seems likely.However to determine an exact root cause, device investigation at the explanted device would be necessary.No date for a possible re-implantation date has been scheduled yet.This is a final report.
Additional Manufacturer Narrative
Based on the available information from the field, a technical implant failure seems likely and it would explain the initially reported lack of benefit with the device.However, to determine an exact root cause, device investigation would be necessary.Re-implantation was carried out, but the device has not been received yet.Reportedly, the explantation was done because the user's hearing has returned to normal and the device was anyway no longer needed.This is a final report.
Event or Problem Description
The user came in (b)(6) 2022 to upgrade the audio processor (ap) after his previous ap broke.The user has not been able to hear any sound since that time.Initially the user denied any falls or head trauma but according to additional information there was trauma to the device.In (b)(6) 2023 it was communicated that the user's hearing has returned to normal and this was the primary reason for the explantation in (b)(6) 2023.

• 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 ; 57788
• MDR Report Key: 14485973
• Report Number: 9710014-2022-00355
• Device Sequence Number: 4613427
• Product Code: PFO
• UDI-Device Identifier: 09008738521805
• UDI-Public: (01)09008738521805
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: BCI601 BONE CONDUCTION IMPLANT
• Device Catalogue Number: 52180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 05/19/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/18/2022; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male