MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1200 SYNCHRONY PIN

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 was implanted in may 2022 and the site healed completely and there were no concerns at device activation.However, about 2 weeks after activation problems were noted and when the user was seen on the 6th july there was a superficial infection (scabbing/debris).Additional information received on (b)(6) 2023 stated that the user is doing extremely well with the device but has been dealing with skin flap issues again and the electrode lead extruded through the skin.

Manufacturer Narrative

Additional information: according to the information received from the field the recipient suffered from re-occurring infection and skin flap issues at the implant site causing an extrusion of the electrode through the skin.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 the reported issue.However, the presence of the device might have contributed to its subsequent development.Reportedly the user has very thin skin which might have contributed to the observed event.Currently the recipient is using antibiotics and is monitored by the clinic.This is a final report.

Event Description

The user was re-implanted with this device in (b)(6) 2022 and the surgical site healed completely and there was no sign of infection at device activation.However, about 2 weeks after activation on (b)(6) 2022, there was a superficial infection (scabbing/debris) noted on the incision line.The user was seen on the (b)(6) 2022 and the site looked much better.It had not completely healed and there was a small area of pink skin.The user continued to use the antibiotic cream.When the user was seen at the end of (b)(6) 2022 there was still a few millimeters of skin left to heal.However, the user was wearing a rondo 3 so as to not rub on the affected area and was very pleased with the device performance.Additional information received on 19th october 2023 stated that the user was doing extremely well with the device but had been dealing with skin flap issues again and the electrode lead extruded through the skin at the incision site.It was decided to monitor the area rather than do a skin flap revision.Per information received (b)(6) 2023, the surgical site looked clear.The user was continuing to use the antibiotic cream.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 18117945
• MDR Text Key: 327888572
• Report Number: 9710014-2023-01020
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2024
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 01/15/2024
• Date Device Manufactured: 04/14/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female