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

Model Number MI1250 SYNCHRONY 2

Device Problem Impedance Problem (2950)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

The user has reported experiencing echo effects and a decline in hearing performance over the past six months.The user has expressed consideration for a reimplantation, but is still uncertain.

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 Description

The user has reported experiencing echo effects and a decline in hearing performance over the past six months.The user has been reimplanted on (b)(6) 2024.

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.The problems given in the recipient report appear to match the damage found.This is a final report.

• Brand Name: SYNCHRONY
• Type of Device: 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: 18796825
• MDR Text Key: 336527066
• Report Number: 9710014-2024-00190
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female