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 Problems Pain (1994); Dizziness (2194)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

Reportedly the user was hearing noise on the implanted side and so she stopped using the external processor for a few days.However, the noise was also heard without the audio processor and with wearing the processor but at zero map.The sound is louder though when the device is in use.Additionally, the user also experiences severe physical pain in the area of the implant housing from pressure applied with occasional dizziness.The severe pain is also present when the processor is not activated.Re-implantation took place on (b)(6) 2020.Per explantation report form information, one channel was found out of the cochlea.

Event Description

Reportedly the user was hearing noise on the implanted side and so she stopped using the external processor for a few days.However, the noise was also heard without the audio processor and with wearing the processor on a zero map.The sound is louder though when the device is in use.Additionally, the user also experiences physical pain in the area of the implant housing when pressure is applied.The user also experiences occasional dizziness.The severe pain is also present when the audio processor is not activated.Re-implantation took place on (b)(6) 2020.

Manufacturer Narrative

Conclusion: investigation results confirm loss of hermeticity at the housing braze joint by micro-leaks that may lead to device electronics failure over time.It appears that the device is in an early stage of failure.Over a certain period of time, humidity will impinge on the electronics and cause damage, finally leading to complete failure of the circuitry.In addition, the recipient was experiencing dizziness and pain due to undetermined reasons.Reportedly, one channel was observed to be outside of the cochlea at the time of explantation.A minor migration of the active electrode array may be assumed as a full insertion was reported during implantation surgery.The investigation results seem to match the symptoms mentioned in the patient report.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: 10188232
• MDR Text Key: 196210982
• Report Number: 9710014-2020-00333
• 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
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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: 04/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR