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

Model Number MI1210 SYNCHRONY ST

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.The user's mother realized that he could no longer hear 2 days ago.

Manufacturer Narrative

Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

The hearing performance with the device is affected.Reportedly the loss of benefit was sudden.Re-implantation is considered.

Manufacturer Narrative

Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The hearing performance with the device was affected.Reportedly the loss of benefit was sudden.The user was re-implanted on (b)(6) 2021.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• MDR Report Key: 11639547
• MDR Text Key: 244634586
• Report Number: 9710014-2021-00240
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2020
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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: 5 YR