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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Codes	Headache (1880); Failure of Implant (1924)
Date of Event	05/10/2021
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's hearing performance with the device is affected.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experienced shocking sensations and headaches during use of the audio processor.The headaches are also present without the use of the audio processor, but are exacerbated by use of the implant.The reported issues are known undesired side-effects of cochlea implantation.Further several channels have been disabled due to the reported uncomfortable sensations.However, after medication the recipient is doing fine.The device remains implanted and in use.
Event or Problem Description
The user's hearing performance with the device is affected.The user attended the hospital er in march with severe headaches and he also described a shocking sensation.The user hasn't worn the processor for several months and still was experiencing the headaches.The headaches are significantly worse during the use of the device.The problems had started between (b)(6) 2019 and (b)(6) 2020.He has shooting pains about 3 cm above his ci, and a dull ache and mild palpable tenderness, he is also suffering from episodic vertigo.Shooting sensation is present with and without the device, however the shocking sensation is only present with the device.According to an update from the clinic from the (b)(6) 2021 the user is now stable after seen by the pain management clinic.

• 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: 11884032
• Report Number: 9710014-2021-00385
• Device Sequence Number: 3709891
• Product Code: MCM
• UDI-Device Identifier: 09008737094027
• UDI-Public: (01)09008737094027
• 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: 2019
• 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): 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/21/2021
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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: 40 YR
• Patient Sex: Male