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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user complaint that the audio with the device is too low.The clinic noticed swelling located on the left side of the head, near the receiver/stimulator in (b)(6) 2022.Imaging will be performed, revision surgery 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.
Event or Problem Description
The user complained in the previous months that the volume with the device was too low.Additionally, the clinic noticed swelling located on the left side of the head, near the receiver/stimulator in (b)(6) 2022.The user was given antibiotics for the swelling and the swelling was reduced.Explantation surgery was performed on (b)(6) 2022 and the electrode array was left in place for future reimplantation.Granulated tissue was seen during the explantation surgery.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.In addition, during explantation granulation tissue around the housing was found.Cultures thereof isolated staphylococcus epidermidis, which is a resident of healthy human skin of the anatomic site of implantation.Considering the proper sterilization of the device, a device-related infection can be likely excluded.Furthermore, an incomplete insertion has been reported with 2 extra-cochlear channels, as confirmed by diagnostic imaging at implantation.The problems given in the recipient report appear to match the damage found.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: 13757748
• Report Number: 9710014-2022-00186
• Device Sequence Number: 11373028
• Product Code: MCM
• UDI-Device Identifier: 09008737094034
• UDI-Public: (01)09008737094034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 03/08/2021
• Device Model Number: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2018
• 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: 4 YR
• Patient Sex: Male