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

Model Number C40+

Device Problems Circuit Failure (1089); Output Problem (3005)

Patient Problems Failure of Implant (1924); Tinnitus (2103); Dizziness (2194)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

The user is reported to be a successful user of the device.On (b)(6) 2019 the user reported headaches and tinnitus and a beeping sensation from the device.In situ testing done at that time was unremarkable.The user denies any trauma and there is no report of changes in health.The device has been explanted.

Event Description

The user is reported to be a successful user of the device.On (b)(6) 2019 the user reported headaches and tinnitus and a beeping sensation from the device.In situ testing done at that time was unremarkable.The user denies any trauma and there is no report of changes in health.

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.In addition the recipient reported dizziness and tinnitus when using the device, which are known post-operative side effects of otologic surgery.These symptoms are also present with the new device.The problems described in the recipient report appear to match the damage found.This is a final report.

Event Description

The user is reported to be a successful user of the device.On (b)(6) 2019 the user reported headaches and tinnitus and a beeping sensation from the device.In situ testing done at that time was unremarkable.The user denies any trauma and there is no report of changes in health.The user was re-implanted.

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: 9672337
• MDR Text Key: 177831140
• Report Number: 9710014-2020-00083
• 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,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 02/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR