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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Therapeutic Effects, Unexpected (2099)
Date of Event	01/06/2021
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
The recipient's hearing performance with the device is affected.Imaging confirmed that the electrode array is not completely inserted in the cochlea.Surgery to reinsert array is scheduled on (b)(6) 2021.
Additional Manufacturer Narrative
Conclusions: device investigation did not reveal any device defect or damage which is expected to have been present whilst implanted after first surgery.Damages found during device investigation are likely related to the explantation surgery or possibly to the reinsertion attempts done at revision surgery.During investigation the device is working within specification.According to the received information, the device was explanted because it was not providing benefit to the recipient due to a medical reason, namely the active electrode migrated post-operatively out of the cochlea because of ossification and growth of fibrotic tissue, as confirmed by post-operative diagnostic imaging.The recipient was re-implanted with a device from another manufacturer.This is a final report.
Event or Problem Description
The recipient's hearing performance with the device was affected.At a revision surgery on (b)(6) 2021 it was confirmed that only 2-3- contacts of the electrode were still inside the cochlea and the rest were extra-cochlear.According to the surgeon, the electrode aray had been pushed out by ossification and fibrotic growth.Despite efforts the array could not be inserted any further and therefore it was left in place at the same insertion depth.Afterwards, the user could detect auditory sensation on 2 active electrodes.The user was re-implanted with a competitor's device on (b)(6) 2021.At re-implantation it was confirmed that ossification at the basal turn pushed the electrode out of the cochlea.

• 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: 11146800
• Report Number: 9710014-2021-00009
• Device Sequence Number: 19400603
• Product Code: MCM
• UDI-Device Identifier: 09008737366773
• UDI-Public: (01)09008737366773
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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 Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: 60 YR