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

Model Number MI1200 SYNCHRONY

Device Problems Device Appears to Trigger Rejection (1524); Output Problem (3005); Migration (4003)

Patient Problems Failure of Implant (1924); Tissue Damage (2104); Skin Tears (2516); Tissue Breakdown (2681)

Event Date 01/14/2020

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 attended an appointment on (b)(6) 2020 because there was no longer hearing performance with the device.The doctor confirmed a middle ear infection and suspected that the electrode has migrated out of the cochlea.Imaging confirmed migration of the electrode, namely ct scan from (b)(6) 2019 showed that the electrode array migrated out of the cochlea and extrusion of the electrode through ear was visible through video otoscopy on (b)(6) 2020.Migration was first suspected in (b)(6) 2018 when the recipient complained of reduced speech discrimination and uncomfortable stimulation with increased levels.The infection reportedly started on (b)(6) 2019 and has extended to the exposed electrode and post-auricular area since.Explantation is scheduled for (b)(6) 2020.

Manufacturer Narrative

Conclusion: according to the received information from the field, the electrode array migrated post-operatively out of cochlea and was found extruded into the ear canal.Reportedly the recipient experienced a middle ear infection, however the contribution of it cannot be determined.Furthermore, damage to the active electrode caused by device minute mobility were observed during investigation.The latest ct scan showed an ossification of the cochlea in the basal turn, which was not present during implantation surgery and also was not seen in recent ct scans.Other mechanical damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

The user attended an appointment on (b)(6) 2020 because there was no longer hearing performance with the device.The doctor confirmed a middle ear infection and suspected that the electrode has migrated out of the cochlea.Imaging confirmed migration of the electrode, namely ct scan from (b)(6) 2019 showed that the electrode array migrated out of the cochlea and extrusion of the electrode through ear was visible through video otoscopy on (b)(6) 2020.Migration was first suspected in may 2018 when the recipient complained of reduced speech discrimination and uncomfortable stimulation with increased levels.The infection reportedly started on (b)(6) 2019 and has extended to the exposed electrode and post-auricular area since.The user was explanted.

• 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: 9692594
• MDR Text Key: 178638503
• Report Number: 9710014-2020-00099
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR