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 Headache (1880); Failure of Implant (1924); Pain (1994)

Event Date 06/11/2020

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 was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.She also had some sensation of pain and headaches.The user did try the rondo 2 but could hear only a really low volume.An opus 2 was given to the user and she has hearing benefit with it, but she hears noise ("liquid or bubbles noises").She is currently using the opus 2 processor.

Event Description

The user was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.The user did try the rondo 2 audio processor but could hear only a really low volume.An opus 2 audio processor was given to the user and she had hearing benefit with it, but she hears noise ("liquid or bubbles noises").She is currently using the opus 2 audio processor.Re-implantation is considered, but no date has been scheduled yet.

Manufacturer Narrative

Additional information: as per the complaint information and the manufacturer_s experience with this kind of device, 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 a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.

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 was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.The user did try the rondo 2 audio processor but could hear only a really low volume.An opus 2 audio processor was given to the user and she had hearing benefit with it, but she hears noise ("liquid or bubbles noises").She then used opus 2 audio processor.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: 10199011
• MDR Text Key: 196987940
• Report Number: 9710014-2020-00344
• 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: 10/28/2021

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: 10/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 06/17/2020
• Supplement Dates FDA Received: 09/15/2020; 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR