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

Model Number C40+

Device Problems Circuit Failure (1089); Intermittent Continuity (1121)

Patient Problem Failure of Implant (1924)

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 user reports intermitted function of the cochlear implant in terms of varying loudness and crackling sounds.

Event Description

The user reports intermittent function of the cochlear implant with varying loudness and crackling sounds.

Manufacturer Narrative

Additional information: according to the complaint information and the manufacturer_s experience with this kind of devices, it is assumed that the device might have failed due to humidity ingress at the housing braze joint through micro-leaks.However to determine an exact root cause of failure a device investigation of the explanted device is necessary.Explantation is considered but no further information has been received.

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.

Event Description

The user reports intermittent function of the cochlear implant with varying loudness and crackling sounds.The user has been re-implanted.

• 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: 10904081
• MDR Text Key: 218927680
• Report Number: 9710014-2020-00705
• 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,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 04/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR