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

Model Number MI1250 SYNCHRONY 2 PIN

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

Patient Problem Bacterial Infection (1735)

Event Date 09/12/2022

Event Type  Injury  

Event Description

The user suffered from an mrsa cellulitis infection over the implant housing.Despite antibiotic treatment there was then around 4mm of extrusion along the interior side of the implant housing.Reportedly the electrode was also visible along the posterior aspect of the mastoid cavity.The mastoid cavity appeared to be healthy with no evidence of infection.An explant kit was requested and the device was explanted on the (b)(6) 2022.

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.

Manufacturer Narrative

Conclusion: device investigation of the received parts 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 device was explanted due to an infection at the implant site and extrusion of the device through the skin.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.This is a final report.

Event Description

The user suffered from an mrsa cellulitis infection over the implant housing.Despite antibiotic treatment there was then around 4mm of extrusion along the interior side of the implant housing.Reportedly the electrode was also visible along the posterior aspect of the mastoid cavity.The mastoid cavity appeared to be healthy with no evidence of infection.The device was explanted.

• 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: 15452931
• MDR Text Key: 300222309
• Report Number: 9710014-2022-00686
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395421
• UDI-Public: (01)09008737395421
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 39570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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: 66 YR
• Patient Sex: Female