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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Type of Reportable Event	Malfunction
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 was implanted in 2014 but was not able to hear well with the device after implantation and speech discrimination did not develop.Re-fitting was done but the issue was not resolved.After more refitting the user was able to hear sounds better but there was still no speech discrimination.X-rays determined that the electrode array had a tip fold over in the cochlea.The recipient requested to have the device explanted.
Additional Manufacturer Narrative
Additional information: according to the received information from the field, the recipient did not develop speech discrimination with the implant system since implantation.Diagnostic imaging confirmed a tip fold-over of the electrode array which is likely the reason for the perceived no benefit.Re-implantation is considered, but no date has been scheduled yet.This is a final report.
Event or Problem Description
The recipient was implanted in 2014 but was not able to hear well with the device after implantation and speech discrimination did not develop.Re-fitting was done but the issue was not resolved.After more refitting the user was able to hear sounds better but there was still no speech discrimination.The recipient requested to have the device explanted.

• 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: 9646434
• Report Number: 9710014-2020-00067
• Device Sequence Number: 502480
• Product Code: MCM
• UDI-Device Identifier: 09008737062750
• UDI-Public: (01)09008737062750
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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 Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR