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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
During an appointment in (b)(6) 2021, it was noted that the user had a poor auditory response and the in-situ measurements showed abnormal results.The user has been reimplanted on (b)(6) 2021.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.In addition in situ measurements in (b)(6) 2019 showed one channel with hi status due to undetermined reasons and returned back to normal.However, to determine an exact root cause a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.If the device is received in the future, the case will be re-opened and the device investigated.
Event or Problem Description
During an appointment in (b)(6) 2021, it was noted that the recipient had a poor auditory response and the in-situ measurements showed abnormal results.The recipient has been re-implanted on (b)(6) 2021.Despite requested, the concerned device has not been received for investigation.
Additional 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 or Problem Description
During an appointment in (b)(6) 2021, it was noted that the recipient had a poor auditory response and the in-situ measurements showed abnormal results.The recipient has been re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 12893292
• Report Number: 9710014-2021-00951
• Device Sequence Number: 17009117
• Product Code: MCM
• UDI-Device Identifier: 09008737062767
• UDI-Public: (01)09008737062767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2020
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 11/29/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/19/2022; 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male