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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The user's right-sided implant was explanted.Reports indicated that the implant extruded and there was infection and necrosis in the surrounding implant area.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the implant extruded through the skin post-operatively.Infection and necrosis was observed.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 the reported issue.However, the presence of the device might have contributed to its subsequent development.The explanted device has not been received for investigational purposes yet.
Event or Problem Description
The user's right-sided implant was explanted.Reports indicated that the implant extruded and there was infection and necrosis in the surrounding implant area.
Event or Problem Description
The user's right-sided implant was explanted.Reports indicated that the implant extruded and there was infection and necrosis in the surrounding implant area.The user has been re-implanted with a new device on (b)(6) 2024.
Additional Manufacturer Narrative
Conclusion: device investigation of the received parts did not reveal any device damage or defect, which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the implant extruded through the skin post-operatively.Infection and necrosis was observed.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 the reported issue.However, the presence of the device might have contributed to its subsequent development.This is a final report.

• 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: 19769356
• Report Number: 9710014-2024-00633
• Device Sequence Number: 8605203
• Product Code: MCM
• UDI-Device Identifier: 09008737395346
• UDI-Public: (01)09008737395346
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/13/2026
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 07/10/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/01/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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: 25 MO
• Patient Sex: Female