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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The link check in the dl coil also shows a red flashing when over the implant.The mother reports that the child reacted.In the last week it fell on the playground on its head on the implanted side ,no swelling visible over the implant.Reimplantation is scheduled as soon as possible.
Event or Problem Description
Abnormalities were detected during a routine check in the clinic.No result could be measured during in situ measurements and the implant serial number could not be read out.The link check in the dl coil also showed a red flashing when over the implant.The mother reported that the child reacted.In the week before the check, the user fell in the playground on his head on the implanted side, but no swelling was visible over the implant.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusions: device investigation revealed multiple fatigue fractures of electrode wires in the area of the silicone overmold and at fantail.In addition, damage of the feed through to the coil was found and the protectors in front of the housing were bent.These findings are indicative of repeated mechanical stress of unknown intensity to the implant.Then ultimate failure of the device was likely caused by the reported impact, which affected parts already weakened by fatigue.In fact, further investigation of the feed through pin revealed a combination of fatigue and overload fracture.The problems described in the recipient report seem to match the found damages.This is a final report.

• 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: 16910615
• Report Number: 9710014-2023-00395
• Device Sequence Number: 15297555
• Product Code: MCM
• UDI-Device Identifier: 09008737366803
• UDI-Public: (01)09008737366803
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/05/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/11/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36709
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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: 29 MO
• Patient Sex: Male