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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Implant Pain (4561)
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
After implantation the user felt pain at the implant area.When it was investigated, it seemed that no implant bed was drilled and there was buckling of the skin at the magnet site.After the revision, pain was temporarily gone, but sometime after came back (around summer 2022).Pain is at the implant area and the user is not able to wear coil over the implant for a long time because of pain.A revision surgery was done in november 2021 where the implant place was changed to be symmetrical with the contralateral implant site and proper implant bed and attachment were done.A revision surgery is planned but no date has been provided yet.
Event or Problem Description
After implantation the user felt pain at the implant site.During troubleshooting, it was detected that no implant bed was drilled and there was buckling of the skin at the magnet site.A revision surgery was done in (b)(6) 2021 where the implant place was changed to be symmetrical with the contralateral implant site and proper implant bed and attachment were done.After the revision, pain was temporarily gone, but eventually came back (around summer 2022).Pain is located at the implant area and therefore the user is not able to wear the coil for a long time.The device has been explanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experienced pain after first implantation most likely due to excessive pressure from the internal device on the skin, since no implant bed was prepared to properly accommodate it.Therefore, a revision surgery was performed that seemed to temporarily solve the issue.However, after some time the pain in the implant area reappeared.Reportedly the device was working within specification.Diagnostic imaging showed some findings that were not further specified, although requested, but that finally led to the decision to explant the device.During device removal, inflamed tissue was observed in the mastoid and implant site.However, since no relevant information about the observed tissue has been provided, it is not possible to determine the cause for the reported problem, which could include an unspecified inflammatory reaction or an infection.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no information available points to the implant being the source of infection.However, a device contribution to the subsequent development of the inflammation cannot be ruled out.The explanted device has not been received for investigation yet.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: 15238470
• Report Number: 9710014-2022-00595
• Device Sequence Number: 17754039
• Product Code: MCM
• UDI-Device Identifier: 09008737366193
• UDI-Public: (01)09008737366193
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 03/08/2023

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: 06/08/2024
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 36631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: 29 YR
• Patient Sex: Female