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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Circuit Failure (1089); No Device Output (1435)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/27/2023
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
Hearing performance with the device is affected.Two weeks ago, the user was watching tv without the processor on.He began hearing a low rumbling sound; he explained the sound as a humming/whirring sound that a machine would make if rotating.He immediately went to put the processor on his head and the sound was very loud and headache inducing.The headache went away after a few minutes of removing the processor.The user did not wear the processor again until last week.At this time, he saw his aud who turned everything down until it was at a level he could tolerate.The user has been wearing it like this for the last week but perceives no benefit with the processor turned to this level.
Additional Manufacturer Narrative
Conclusion: device investigation confirmed that stimulator electronics is working according to specifications.However, a reduced electrical impedance between coil and eap/rg (evoked action potentials/ remote ground) electrode was discovered during investigation, which very likely caused the reported issues.This is a final report.
Event or Problem Description
Two weeks ago (end of (b)(6) 2023), the user was watching tv without the processor on.He began hearing a low rumbling sound; he explained the sound as a humming/whirring sound that a machine would make if rotating.He immediately went to put the processor on his head and the sound was very loud and headache inducing.The headache went away after a few minutes of removing the processor.The user did not wear the processor again until last week.At this time, he saw his aud who turned everything down until it was at a level he could tolerate.The user has been wearing it like this for the last week but perceives no benefit with the processor turned to this level.The user was re-implanted.

• 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: 18362502
• Report Number: 9710014-2023-01128
• Device Sequence Number: 18120796
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• 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
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 10/15/2024

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: 10/01/2022
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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: 11 YR
• Patient Sex: Male