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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Codes	Circuit Failure (1089); No Device Output (1435)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user reports that since 2 weeks he hears 3 "beeps" when he puts on the external device.Everything else is working normally and his hearing is normal.In situ measurements could not be performed due to integrity failure.There have been no recent changes in health or medication.According to new information from 26.Mar.2024 there was some leakage of the device.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.However, to determine an exact root cause device investigation of the explanted device would be necessary.No information on possible further steps has been received.
Event or Problem Description
The user reports that since 2 weeks (beginning of (b)(6) 2024) he hears 3 "beeps" when he puts on the external device.Everything else is working normally and his hearing is normal.Exchange of the device was recommended.
Additional Manufacturer Narrative
Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.The failure of the electronic circuitry was probably caused by humidity ingress through micro leaks, which exact location could not be identified during device investigation.Over a certain period of time, humidity will impinge on the electronics and cause damage, potentially leading to complete failure of the circuitry.This is a final report.
Event or Problem Description
The user reports that in the last 2 weeks (around beginning of (b)(6) 2024) he hears 3 "beeps" when he puts on the external device.Everything else is working normally and his hearing is normal.The user was reimplanted.

• 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: 19032533
• Report Number: 9710014-2024-00305
• Device Sequence Number: 18184461
• Product Code: MCM
• UDI-Device Identifier: 09008737093976
• UDI-Public: (01)09008737093976
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 05/02/2025

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: 06/07/2019
• Device Model Number: MI1200 SYNCHRONY 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: 03/21/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 03/21/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/27/2024; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2016
• 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: 39 YR
• Patient Sex: Male