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

Model Number MI1250 SYNCHRONY 2

Device Problems Circuit Failure (1089); No Device Output (1435)

Patient Problem Failure of Implant (1924)

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

On (b)(6) 2023 the user was seen in the clinic and there was no communication with the processor.The link check would only flash red.With troubleshooting and providing replacement devices (external), the problem still could not be remedied.The user was seen again on (b)(6) 2023 and the problem still persisted.Re-implantation has been scheduled.

Event Description

On (b)(6), 2023 the user was seen in the clinic and there was no communication with the processor.The link check would only flash red.The user was seen again on (b)(6), 2023 and the problem still persisted.The user had no more benefit with the device.The user was re-implanted on (b)(6), 2023.

Manufacturer Narrative

Conclusions: device investigations revealed the substrate of the device circuitry to be broken.The investigation results appear to match the problems mentioned in the recipient report.The exact reason for the crack in the substrate cannot be determined.However, a review of the dhr has been performed and it was confirmed that the device was released according to specifications.Furthermore, before the occurrence of the above issue, two affected channels had been observed due to unknown reasons.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 17018383
• MDR Text Key: 316102689
• Report Number: 9710014-2023-00455
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/06/2024
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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: 7 YR
• Patient Sex: Male