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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.Two months after surgery, 4 channels showed high impedance, but the user was still happy with the sound quality when all channels were active and refused adjustments.10 days ago, the user complained to her family that the sound suddenly became very soft and wired with head movement (sound was present when her head was straight but disappeared when tilted) for 2 days then the sound disappeared.Speech understanding has deteriorated.Re-implantation is considered.
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
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.In addition a complete insertion was not achieved at implantation surgery with two channels remaining extra-cochlear.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user's hearing performance with the device is affected.Two months after surgery, 4 channels showed high impedance, but the user was still happy with the sound quality when all channels were active and refused adjustments.However, mid january 2025, the user complained to her family that the sound suddenly became very soft and wired with head movement (sound was present when her head was straight but disappeared when tilted) for 2 days then the sound disappeared.Speech understanding has deteriorated.The user has bee re-implanted.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.In addition a complete insertion was not achieved at implantation surgery with two channels remaining extra-cochlear.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user's hearing performance with the device is affected.Two months after surgery, 4 channels showed high impedance, but the user was still happy with the sound quality when all channels were active and refused adjustments.However, in (b)(6) 2025, the user complained to her family that the sound suddenly became very soft and wired with head movement (sound was present when her head was straight but disappeared when tilted) for 2 days then the sound disappeared.Speech understanding has deteriorated.Re-implantation is considered.

• 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: 21305021
• Report Number: 9710014-2025-00106
• Device Sequence Number: 8884357
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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 Model Number: MI1250 SYNCHRONY 2
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 01/24/2025; 01/24/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/27/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 51 YR
• Patient Sex: Female