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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to (b)(6) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
The user's hearing performance with the device is affected.Around 6 months after implantation a ct scan showed that 4 channels are out of the cochlea.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: according to the received information, the active electrode migrated partially out of cochlea post-operatively, as confirmed by diagnostic imaging, and a revision surgery was required to reinsert the active electrode array.The device investigation shows damages to the active electrode lead by a sharp instrument and to the electrode contacts, which are typical for occurring during surgical intervention and reinsertion attempts.Reportedly, the damage inadvertently occured during the revision surgery.In addition, a full insertion could not be achieved during initial implantation surgery.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.Around 6 months after implantation a ct scan showed that 4/5 channels were out of the cochlea.At the revision surgery to reinsert the array several contacts of the electrode were damaged by the surgical instruments (med-el claw _ fentex) while trying to reinsert the array.Therefore, the recipient was re-implanted with the back-up device.The array was fully inserted.

• 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: 11327347
• Report Number: 9710014-2021-00100
• Device Sequence Number: 2581527
• Product Code: MCM
• UDI-Device Identifier: 09008737366728
• UDI-Public: (01)09008737366728
• 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: 2021
• 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): 04/15/2021

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: 36701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: 57 YR