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

Model Number C40+

Device Problems Device Appears to Trigger Rejection (1524); Output Problem (3005)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Date 04/21/2021

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 hearing performance is reportedly affected.

Event Description

The hearing performance was reportedly affected.The user had lost her external equipment and has not been seen for programming for about 20 years.It is unknown how her hearing performance was before.

Manufacturer Narrative

Additional information: based on the received information from the field, the recipient was a non-user for more than 20 years.Insufficient benefit from the implant system is now reported.A partial migration of the active electrode out of cochlea could be confirmed by ct imaging.In addition four channels have been extra cochlea since implantation.No further intervention is planned currently.

• 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: 11732337
• MDR Text Key: 247518704
• Report Number: 9710014-2021-00303
• 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
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• 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: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR