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

Model Number C40+

Device Problems Circuit Failure (1089); No Device Output (1435)

Patient Problem Failure of Implant (1924)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

The user reported a sudden high pitch sound followed by shooting pain over the implant site on (b)(6) 2023.Once the external device was removed and replaced a continuous 'drilling' sound was heard followed by a complete absence of sound.The system has not worked since this time.Explantation is considered.

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.

Manufacturer Narrative

Conclusion: in accordance with the information in the patient report and the manufacturers experience with this kind of device, it is assumed that it is possibly in an early stage of failure and is likely to fail sooner or later due to humidity ingress at the housing braze joint through micro-leaks.Only a part the active and reference electrode has been received for investigation purposes.This is a final report.

Event Description

The user reported a sudden high pitch sound followed by shooting pain over the implant site on (b)(6) 2023.Once the external device was removed and replaced a continuous 'drilling' sound was heard followed by a complete absence of sound.The system has not worked since this time.The user has been re-implanted.

Event Description

The user reported a sudden high pitch sound followed by shooting pain over the implant site on (b)(6) 2023.Once the external device was removed and replaced a continuous 'drilling' sound was heard followed by a complete absence of sound.The system has not worked since this time.Re-implantation is considered.

Manufacturer Narrative

Additional information: in accordance with the information in the patient report and the manufacturers experience with this kind of device, it is assumed that it is possibly in an early stage of failure and is likely to fail sooner or later due to humidity ingress at the housing braze joint through micro-leaks.To determine an exact root cause a device investigation would be necessary.Explantation is considered but no date has been scheduled yet.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR 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: 18482227
• MDR Text Key: 332500159
• Report Number: 9710014-2024-00022
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male