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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Dizziness (2194)
Date of Event	01/21/2022
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
Reportedly post-op imaging shows that the active array is extra-cochlear.At initial activation, responses were not seen on the concerned left side.A ct scan will be performed on the (b)(6).
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Damages found during device investigation are most likely related to the explantation surgery.According to the information received from the field the device was explanted due to lack of benefit, which was possibly caused by clinical reasons, as ossification and fibrosis are present in the cochlea due to pre-operative meningitis and the recipient does not receive benefit neither with the new ispilateral device nor with the contralateral one.Furthermore, the active electrode likely migrated postoperatively outside of the cochlea, which might have contributed to a poor performance.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
At initial activation responses were not seen on the concerned side; there were also some problems with balance at activation.In (b)(6) 2022 the clinician indicated post-op imaging seemed to indicate that the active electrode array was extra-cochlear.At initial activation, responses were not seen on the left side, but were seen on the right contralateral side (crying response).At follow-up visit in (b)(6) 2022, the active array was said to be located in the petrous bone because of the ossification and complex surgery.However, a full radiology report was pending.No fitting was carried out for the concerned side at this time, and the left processor cpu was retained by the clinic.The user was re-implanted in (b)(6) 2022.According to the device explant form, there were some extracochlear electrodes.

• 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: 13420773
• Report Number: 9710014-2022-00076
• Device Sequence Number: 17312441
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2024
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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: 25 MO
• Patient Sex: Male