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

Model Number C40+

Device Problem Output Problem (3005)

Patient Problems Ossification (1428); 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

Reportedly, the recipient_s performance using the device is very low.

Event Description

Reportedly, the recipient_s performance using the device was very low.It started to decrease before (b)(6) 2019.Re-implantation is planned, but no date has been scheduled yet.

Manufacturer Narrative

Additional information: based on the available information and measurements from the field, a technical implant failure seems likely.However, to determine an exact root cause a device investigation on the explanted device would be necessary.In addition the reported observed increase in the ground path impedance is likely due to bone growth around the reference electrode.Re-implantation is considered but no date has been scheduled yet.

Manufacturer Narrative

Conclusions: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.Based on the available information and measurements from the field, the cause for the observed performance issues is likely related to the cochlea's physiology.Reportedly ossification was seen during device removal which would explain for the reported issue.In addition, the reported observed increase in the ground path impedance is likely due to bone growth around the reference electrode.Furthermore, an incomplete insertion of the active electrode at the time of implantation is reported, which might have contributed to the lack of benefit.Re-implantation was not possible due to ossification in the cochlea.This is a final report.

Event Description

Reportedly, the recipient_s performance using the device was very low.It started to decrease before july 2019.The device has been explanted but the user could not be re-implanted due to ossification of the cochlea.

• 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: 11918631
• MDR Text Key: 254546223
• Report Number: 9710014-2021-00400
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 49 YR
• Patient Sex: Female