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

Model Number	SONATA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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
Several months after implantation the implant housing started to migrate to the level of the audio processor.Because of pain, the implant housing was repositioned on (b)(6) 2020.After surgery affected channels and a migration of the electrode was noticed.Re-implantation is planned.
Event or Problem Description
Several months after implantation a migration of the implant housing down to the level of the audio processor was noticed.Because of pain, the implant housing was repositioned on (b)(6) 2020.After revision surgery affected channels and extra-cochlea channels were observed.The recipient was re-implanted on (b)(6) 2020.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field the recipient underwent a revision surgery due to pain caused by a implant migration from its intended position.Reportedly after the re-positioning surgery six electrode contacts were found out of cochlea as confirmed with diagnostic imaging, which was most likely caused by device handling during revision surgery.Therefore the concerned device was explanted.The problems described in the recipient report seem 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
• MDR Report Key: 10740469
• Report Number: 9710014-2020-00617
• Device Sequence Number: 3185240
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/30/2020

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: 10/28/2022
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR