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

Model Number	SONATA
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and 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
While the user was undergoing an ear cleaning procedure the electrode lead was found to be in the external auditory canal.Repair of the external auditory canal and re-implantation had been suggested.The user 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 during investigation are attributable to the removal surgery.According to the information received the electrode lead was found in the external ear canal due to undetermined reasons during an ear cleaning procedure.In addition, in situ measurements taken whilst implanted show the ten basal channels with hi status.No damage to the active electrode, which would explain the reported hi channels, was found during investigation.Therefore it is assumed that the electrode array was accidentally pulled out of cochlea during the ear cleaning procedure.This is a final report.
Event or Problem Description
While the user was undergoing an ear cleaning procedure (cerumen removal) the electrode lead was found to be in the external auditory canal.The user was re-implanted on (b)(6) 2020.
Event or Problem Description
While the user was undergoing an ear cleaning procedure the electrode lead was found to be in the external auditory canal.The user was re-implanted on (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the active electrode was seen during an ear cleaning procedure to be present within the external auditory canal.From the received limited information the sequence of events that led to this outcome cannot be determined.However, in situ measurements point to a damaged active electrode, but to confirm, a device investigation on the explanted device would be necessary.The device was explanted but has not been received for investigational purposes.

• 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: 10452678
• Report Number: 9710014-2020-00463
• Device Sequence Number: 17154774
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2020

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: 01/11/2021
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 08/12/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/05/2020; 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: 64 YR