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

Model Number C40+

Device Problem Circuit Failure (1089)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

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 april (b)(6) 2021 that she has not output from the device.She had last worn the device 4 weeks ago when it had functioned.

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.Further steps will be discussed.

Event Description

The user reported on april 30, 2021 that she has no output from the device.She had last worn the device 4 weeks ago when it had functioned.She wears her audio processor very infrequently.The user did not report any pain or discomfort.At her previous appointment, the audio processor was given back to the clinic, so she hasn_t worn anything since.The user reports the same information as previously mentioned along with comments that she had heard strange noises in the background when using the audio processor.A re-implantation is uncertain at this time.

Manufacturer Narrative

Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.Based on the manufacturer's experience with this kind of devices, it can be assumed that the device has failed due to loss of hermeticity at the housing braze joint.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

Event Description

The user reported on (b)(6) 2021 that she has no output from the device.She had last worn the device 4 weeks ago when it had functioned.She wears her audio processor very infrequently.The user did not report any pain or discomfort.At her previous appointment, the audio processor was given back to the clinic, so she hasn_t worn anything since.The user reports the same information as previously mentioned along with comments that she had heard strange noises in the background when using the audio processor.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
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 11775305
• MDR Text Key: 249004948
• Report Number: 9710014-2021-00327
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 04/30/2021
• Supplement Dates FDA Received: 07/02/2021; 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female