MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Model Number C40+

Device Problems Circuit Failure (1089); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 01/07/2021

Event Type  Injury  

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 hearing performance using the device is affected.On (b)(6) 2021 the user experienced a short circuit like, inconstant noise, beside the speech signal and therefore stopped to wear the audio processor.The user also reported a previous noise sensation similar to tinnitus in (b)(6) 2020 which was reduced after a fitting adjustment.

Event Description

The hearing performance using the device is affected.On (b)(6) 2021 the user experienced a short circuit like, inconstant noise, beside the speechsignal and therefore stopped to wear the audio processor.The user also reported a previous noise sensation similar to tinnitus in (b)(6) 2020 which was reduced after a fitting adjustment.The recipient was re-implanted on (b)(6) 2021.

Manufacturer Narrative

Conclusion: device investigation confirmed that the stimulator electronics failed.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leaks at the housing braze joint.Other damages found during investigation are most likely related to explantation surgery.The problems described in the recipient report appear to match the damage found.This is a final report.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11176271
• MDR Text Key: 228220838
• Report Number: 9710014-2021-00022
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR