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

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation confirmed a malfunction of the device.The root cause for the failure is a non-hermetic transducer due to a defect feedthrough which led to loosening of the internal part of the transducer housing.The problems described in the recipient report appear to match the damage found.This is a combined initial and final report.
Event or Problem Description
The user's hearing performance with the device was affected.The user reported a shocking sensation around the implant site which also extends to her right ear and cheek.She reports this sensation with the audio processor (ap) in place and also when not wearing the ap.Re-implantation took place on (b)(6) 2021.

• Brand Name: BONEBRIDGE
• Common Device Name: BCI BONE CONDUCTION IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 12105886
• Report Number: 9710014-2021-00473
• Device Sequence Number: 11912452
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BCI601 BONE CONDUCTION IMPLANT
• Device Catalogue Number: 52180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR