MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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 user has experienced non-auditory stimulation/perception on much of the electrode array since activation on (b)(6) 2021.The user had a follow-up appointment on (b)(6) 2021 in which shocking sensation was felt intense and sharp.Since the most recent programming it is reported that there is no discomfort with sound at home however the sound is described as very muffled and not speech-like.Imaging is planned to check the placement of the electrode.
Event or Problem Description
The user experienced non-auditory stimulation/perception with stimulation on most of the electrode array since activation on the (b)(6) 2021.The sensation was described as a discomfort or shocking sensation that felt intense and sharp, similar to the pressure sensation felt initially.No facial nerve stimulation or vestibular disturbance were observed.Channels 1-6 were left enabled after activation and the user was able to wear this map consistently for two weeks.Programming sessions were then performed as there was an increase in non-auditory perception on channels 2-12.The user had follow-up appointments on 23th september and (b)(6) 2021 at which shocking sensations and pressure like pain were reported.The user sought a second opinion and was scheduled to be seen the week of the (b)(6)2022, however no further information on whether this took place has been received.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the recipient experienced non-auditory sensations post-operatively i.E.Pain due to stimulation and uncomfortable sensations, which could be known undesired side effects of ci implantation.Fitting sessions have been taken place in order to eliminate the reported issues, and triphasic stimulation seems to have reduced the discomfort.The device remains currently implanted and the recipient will be monitored by the clinic.No further information has been received.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the recipient experienced non-auditory sensations post-operatively i.E.Pain due to stimulation and uncomfortable sensations, which could be known undesired side effects of ci implantation.Fitting sessions have been taken place in order to eliminate the reported issues, and triphasic stimulation seems to have reduced the discomfort.However, latest information received stated that the recipient opted for re-implantation, but no further information has been received yet.
Event or Problem Description
The user experienced non-auditory stimulation/perception with stimulation on most of the electrode array since activation on the (b)(6) 2021.The sensation was described as a discomfort or shocking sensation that felt intense and sharp, similar to the pressure sensation felt initially.No facial nerve stimulation or vestibular disturbance were observed.Channels 1-6 were left enabled after activation and the user was able to wear this map consistently for two weeks.Programming sessions were then performed as there was an increase in non-auditory perception on channels 2-12.The user had follow-up appointments on (b)(6) and (b)(6) 2021 at which shocking sensations and pressure like pain were reported.As per new information received on march 27, 2024 the user has decided to proceed with explantation.Surgery is scheduled some time after (b)(6) 2024.Despite requested, no further information was received.
Additional Manufacturer Narrative
Based on the received information from the field, the recipient experienced non-auditory sensations post-operatively i.E.Pain due to stimulation and uncomfortable sensations, which could be known undesired side effects of ci implantation.Fitting sessions have been taken place in order to eliminate the reported issues, and triphasic stimulation seems to have reduced the discomfort.However, the device was eventually explanted but has not been received for investigation yet.
Event or Problem Description
The user experienced non-auditory stimulation/perception with stimulation on most of the electrode array since activation on (b)(6) 2021.The sensation was described as a discomfort or shocking sensation that felt intense and sharp, similar to the pressure sensation felt initially.No facial nerve stimulation or vestibular disturbance were observed.Channels 1-6 were left enabled after activation and the user was able to wear this map consistently for two weeks.Programming sessions were then performed as there was an increase in non-auditory perception on channels 2-12.The user had follow-up appointments on (b)(6) 2021 at which shocking sensations and pressure like pain were reported.As per new information received on march 27, 2024 the user has decided to proceed with explantation.The device was explanted.

• Brand Name: SYNCHRONY
• 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: 12575289
• Report Number: 9710014-2021-00743
• Device Sequence Number: 3322273
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• 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: 2021
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 10/28/2024

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 Expiration Date: 07/31/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39571
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 09/28/2021; 09/28/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 08/03/2022; 07/11/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female