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

Model Number C40+

Device Problems Circuit Failure (1089); Device Operates Differently Than Expected (2913); Output Problem (3005)

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 recipient has no hearing sensation with the device.Re-implantation is considered.

Manufacturer Narrative

Additional information: according to 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 of failure a device investigation of the explanted device is necessary.Furthermore in situ measurements showed one channel in hi status due to undetermined reasons.Re-implantation is considered but no date has been scheduled yet.

Event Description

The recipient has no hearing sensation with the device.There was no swelling over the implant site.Re-implantation is considered but a date has not been scheduled.

Manufacturer Narrative

Additional information: according to 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 of failure a device investigation of the explanted device is necessary.Furthermore in situ measurements showed one channel in hi status due to undetermined reasons.The recipient was re-implanted, but the device has not been received for investigation yet.

Event Description

The recipient has no hearing sensation with the device.There was no swelling over the implant site.The recipient has been re-implanted but the device has not been received for investigation.

Event Description

The recipient no longer has any hearing sensation with the device.There was no swelling over the implant site.The recipient has been re-implanted.

Manufacturer Narrative

Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leaks at the housing braze joint.Over a certain period of time, humidity will impinge on the electronics and cause damage, potentially leading to complete failure of the circuitry.Additionally, minor damage to the active electrode, likely caused by minute device mobility, was found.The problems given 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: 7662139
• MDR Text Key: 113187988
• Report Number: 9710014-2018-00493
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/10/2019

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: Health Professional
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 06/25/2018; 06/25/2018
• Supplement Dates FDA Received: 07/11/2018; 03/15/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR