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

Model Number MI1250 SYNCHRONY 2

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the recipient suffered from skin infection at the surgical incision.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of reported issue.However, the presence of the device might have contributed to its subsequent development.This is a combined initial and final report.

Event Description

The patient has an infection at the surgical incision which started around (b)(6) 2023.Cultures were positive for staphylococcus aureus.There was no problem related to the implant.The device has been explanted.The user will be re-implanted when the skin problem is solved, the electrode array was left in place for a later reimplantation.

• 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: 18976658
• MDR Text Key: 338548331
• Report Number: 9710014-2024-00280
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 32 YR
• Patient Sex: Female