MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1210 SYNCHRONY ST

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2021

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

Reportedly, the hearing performance with the device is affected and reduced over the last 5 months.

Event Description

Reportedly, the hearing performance with the device is affected and reduced over the last 5 months.The clinic has decided not to re-implant the user at this moment.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is plausible.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is not planned at the moment.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11705694
• MDR Text Key: 246668745
• Report Number: 9710014-2021-00295
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33333
• 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: 16 YR