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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Output Problem (3005); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/10/2020
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
The recipient was implanted with the device on (b)(6) 2020.In situ measurements performed a week later showed affected channels.The recipient was re-implanted.
Additional Manufacturer Narrative
Conclusion: the device investigation shows damage to the silicone body of the active electrode lead, which is typical for occurring during surgical intervention.No other damages have been identified which could explain the reported problem.A dhr confirmed that the device was manufactured and released according to specifications.It is therefore assumed that the device might have been inadvertently damaged during the initial surgery leading to the observed issue over time.This is a final report.
Event or Problem Description
The recipient was implanted with the device on the (b)(6) 2020.In situ measurements performed a week later showed affected channels.The recipient was re-implanted.

• 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: 10859195
• Report Number: 9710014-2020-00676
• Device Sequence Number: 4329213
• Product Code: MCM
• UDI-Device Identifier: 09008737371753
• UDI-Public: (01)09008737371753
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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
• Device Catalogue Number: 37181
• 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: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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: 41 YR