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

Model Number MI1200 SYNCHRONY

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 03/25/2023

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

Reportedly, the user had a recent infection 2 months ago with a complete skin breakdown at the implant site.The user was explanted on (b)(6) 2024.

Event Description

Reportedly, the user had a recent infection 2 months ago with a complete skin breakdown at the implant site.The user was explanted on (b)(6) 2023.

Manufacturer Narrative

Conclusion: device investigations on the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the recipient report the device was explanted because of an infection leading to skin breakdown at the implant site.Reportedly, the recipient has suffered from recurrent ear infections in the past, which might have contributed to the observed issue.A review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of any infection.However, the presence of the device might have contributed to the subsequent skin breakdown.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: 18993700
• MDR Text Key: 338887436
• Report Number: 9710014-2024-00295
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2019
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 04/22/2016
• 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: 74 YR
• Patient Sex: Male