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

Model Number BCI601 BONE CONDUCTION IMPLANT

Device Problems Unexpected Therapeutic Results (1631); Output Problem (3005)

Patient Problems Failure of Implant (1924); Therapeutic Effects, Unexpected (2099)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The user has no auditory response with the device at maximum output.

Manufacturer Narrative

Additional information: according to the received information from the field, a technical device failure is likely.However, to determine an exact root cause an investigation on the explanted device would be necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

The user has no auditory response with the device at maximum output.Re-implantation is considered, but not confirmed as the user is now out of the single sided deafness indication criteria for the device.Despite requested, no additional information could be yet retrieved.

• Brand Name: BONEBRIDGE
• Type of Device: BCI BONE CONDUCTION IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10499174
• MDR Text Key: 207154884
• Report Number: 9710014-2020-00490
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008738515460
• UDI-Public: (01)09008738515460
• Combination Product (y/n): N
• PMA/PMN Number: P990052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BCI601 BONE CONDUCTION IMPLANT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR