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

Model Number C40+

Device Problems Output Problem (3005); Noise, Audible (3273); Unexpected Shutdown (4019)

Patient Problems Failure of Implant (1924); Twitching (2172)

Event Date 12/03/2020

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 reported on (b)(6) 2020 whirring, twitching in his neck and eye and that the processor had turned off.This issue started 2-3 weeks prior the last audiological appointment performed on (b)(6) 2020.

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 reported on (b)(6) 2020 whirring, twitching in his neck and eye and that the audio processor turned off.This issue started 2-3 weeks prior the last audiological appointment performed on (b)(6) 2020.The user was 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: 11019681
• MDR Text Key: 222375755
• Report Number: 9710014-2020-00742
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR