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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Tears (2516); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user was implanted in (b)(6) 2022 and after some time there was swelling in the implant area then the electrode extruded through the skin.Only 5 channels were inserted into the cochlea and 7 channels were left extra-cochlear at implantation due to the user's anatomy.A revision surgery will be performed in a months time.
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 was implanted in (b)(6) 2022 and after some time there was swelling in the implant area then the electrode lead extruded through the skin.The user had two revisions.The first revision was performed on the (b)(6) of (b)(6) 2022 to repair the skin flap.After the surgery imaging showed the electrode array in the middle ear.A second revision was done on the (b)(6) of (b)(6) 2022 and the electrode was reportedly inserted properly into the cochlear.However, clinical support reviewed the images from the (b)(6) of (b)(6) 2022 and they reported that the cochlea appears to be almost fully ossified and some fluid is seen in the first 5-6 mm and only 1-2 channels are reaching the cochlea and the rest of the array is in the middle ear.Reportedly, the user is still wearing the device and is perceiving benefit.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the electrode lead extruded through the skin after implantation surgery.Further a swelling was observed above the implant site.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.In addition, a complete insertion of the electrode array was not achieved at implantation surgery.Information on the implant registration card states that seven channels were left extra-cochlear.Reportedly the recipient suffered from ossification which likely contributed to the incomplete insertion.A revision surgery to repair the skin flap was performed, however afterwards the electrode array was found in the middle ear.Thus a second revision surgery to reinsert the electrode array was performed.However after reinsertion only 1-2 electrode contacts are inside the cochlea.Reportedly the recipient has hearing benefit with the device, which remains implanted and in use.
Event or Problem Description
The user was implanted in (b)(6) 2022 and after some time there was swelling in the implant area then the electrode lead extruded through the skin.The user had two revisions.The first revision was performed on the (b)(6) 2022 to repair the skin flap.After the surgery imaging showed the electrode array in the middle ear.A second revision was done on the (b)(6) 2022 and the electrode was re-inserted, however, only 1-2 channels are reaching the cochlea and the rest of the array is in the middle ear.The device was eventually explanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the electrode lead extruded through the skin after implantation surgery.Further a swelling was observed above the implant site.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.In addition, a complete insertion of the electrode array was not achieved at implantation surgery.Information on the implant registration card states that seven channels were left extra-cochlear.Reportedly the recipient suffered from ossification which likely contributed to the incomplete insertion.A revision surgery to repair the skin flap was performed, however afterwards the electrode array was found in the middle ear.Thus a second revision surgery to reinsert the electrode array was performed.However after reinsertion only 1-2 electrode contacts are inside the cochlea.Reportedly the recipient has hearing benefit with the device, which remains implanted and in use.

• 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: 14998620
• Report Number: 9710014-2022-00495
• Device Sequence Number: 16547581
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 12/22/2024
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 07/06/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 12/27/2022; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 9 YR
• Patient Sex: Female