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	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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 user reported that following mri the area around the implant is sore like a low burn and there is a steady humming that she never had before, like tinnitus.The hearing performance with the device is also affected.
Event or Problem Description
Following mri the area around the implant was sore like a low burn and there was a steady humming, like tinnitus.She also just did not seem to _hear_ anymore.It was more like she was aware of sounds.There was also an odd zapping, like a misfiring sound.Not an actual physical sensation just the sound.Also, since the mri scan the recipient perceived a burning and a spreading headache within a few minutes when placing the audio processor on the head.No pain was reported when the audio processor was not on.At examination on june 11, 2021 the recipient reported a burning sensation on internal device after wearing the telemetry coil for approximately 10-15 minutes and the examiner was able to palpate a warmer spot near approximate location of internal device after the telemetry coil was removed.No obvious bruising opened skin or burning on skin around the implant were observed.Additionally, the recipient was concerned that the internal device had shifted position in her head and was contacting the metal plate in her skull from previous craniotomy due to brain tumor removal.The external equipment has been replaced.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the recipient experienced painful sensation at the implant site during mri examination.The reported symptom is a known possible side-effects of mri examination in combination with ci and can result in inconvenience.These perceptions can depend upon several factors, including induced voltages due to magnetic fields, micro-movement of the device due to the forces exerted by the mri scanner and the sensitivity of the patient.In addition no head bandage was used, which might have contributed to micro movements resulting in the reported issues.However, the recipient reports doing well and no further issues are reported.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 11973964
• Report Number: 9710014-2021-00426
• Device Sequence Number: 4689232
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• 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: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female