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

Model Number C40+

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Tissue Damage (2104)

Event Date 01/28/2020

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

The electrode lead was exposed due to perforation of the posterior wall of the ear canal.The user was re-implanted.

Event Description

The electrode lead was exposed due to perforation of the posterior wall of the ear canal.The user was re-implanted.

Manufacturer Narrative

Device investigation did not reveal any device defect or damage which has been present whilst implanted.This finding was expected because the device was explanted due to an extrusion of the electrode lead into the external ear canal caused by a perforation of the posterior wall.Reportedly an ear cleaning procedure has contributed to the exposure.The investigation results appear to match the problems mentioned in the recipient 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: 9686423
• MDR Text Key: 178327776
• Report Number: 9710014-2020-00095
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR