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

Model Number MI1250 SYNCHRONY 2

Device Problem Lack of Effect (4065)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

The user experienced a sudden worsening in hearing performance and noticed fluctuations in perceived loudness from too soft to too loud.Hearing performance with the device is now unsatisfying.

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 experienced a sudden worsening in hearing performance and noticed fluctuations in perceived loudness from too soft to too loud.Hearing performance with the device is now unsatisfying.Any kind of event that may could have caused that behavior is not given.The user got anti-inflammatory medication.Since then, we found a trend in globally decreasing impedances, thus now situation is comparable to the initial state.Clinicians will continue to observe this, but the situation is solved.

Manufacturer Narrative

Conclusion: based on the received information from the field, the recipient reported temporary loudness fluctuations most likely due to physiological changes in the cochlea.Reportedly the recipient was treated with anti-inflammatory medication and impedance values returned back to normal.No further problems are reported.The device remains implanted and in use.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: 18533412
• MDR Text Key: 333125028
• Report Number: 9710014-2024-00053
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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 Age: 78 YR
• Patient Sex: Female