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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	09/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 family reported the position of device has changed from above to under the helix pushing on the skin.Re-implantation is considered.
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.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the implant housing moved from its intended position.A revision surgery to re-position the device was performed successfully.The device remains implanted and in use.This is a final report.
Event or Problem Description
On (b)(6) 2021, family reported the position of device has changed from above to under the helix pushing on the skin.The mother reported that the implant had continued to move and the distance between the implant and the earlobe has become smaller than the body of the pen.Revision surgery to reposition the implant was performed successfully on (b)(6) 2022.
Event or Problem Description
On (b)(6) 2021 family reported the position of device has changed from above to under the helix pushing on the skin.The mother reported that the implant had continued to move and the distance between the implant and the earlobe had become smaller than the body of the pen.Reportedly, hearing performance with the device was never affected.Revision surgery to reposition the implant was performed successfully on (b)(6) 2022.Per information received on 23-jan-2023, there was redness, swelling and pain at the implant site which started around (b)(6) 2023 and the usage of a headband was recommended.Also, the prescribed medication did not provide any improvement.As the swelling was still present it was decided to perform revision surgery for drainage of the fluid underneath the scalp on (b)(6) 2023.Should the infection remain or return, the device should be removed.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the implant housing moved from its intended position.A revision surgery to re-position the device was performed successfully.However, 3 months later the recipient reported redness, swelling and pain at the implant site.As per the surgeon, the revision surgeries could have caused the swelling.Another revision surgery to drain the fluid is planned.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the implant housing moved from its intended position.A revision surgery to re-position the device was performed successfully.In the post-operative period of the revision surgery an inflamed seroma formation on the surgical incision was observed.Conservative treatment combined with several surgical debridement procedures could not solve the issue, finally leading to device explantation.A review of the device_s sterilization records confirms that proper sterilization was applied at the time of manufacturing.No information available points to the implant being the source of infection.This is a final report.
Event or Problem Description
On 26-sep-2021 family reported the position of device has changed from above to under the helix pushing on the skin.There was no report of an accident/trauma or similar events by the family.The mother reported that the implant had continued to move and the distance between the implant and the earlobe had become smaller than the body of the pen.Reportedly, hearing performance with the device was never affected.Revision surgery to reposition the implant was performed successfully on (b)(6) 2022.

• 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: 15283692
• Report Number: 9710014-2022-00609
• Device Sequence Number: 7091795
• Product Code: MCM
• UDI-Device Identifier: 09008737366193
• UDI-Public: (01)09008737366193
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup,Followup
• Report Date (Section B): 10/04/2023

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: 12/09/2023
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 36631
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 08/23/2022; 08/23/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 11/18/2022; 02/22/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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: 30 MO
• Patient Sex: Female