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

Model Number MI1200 SYNCHRONY

Device Problems Device Appears to Trigger Rejection (1524); Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The user was implanted in (b)(6) of 2020.In the middle of (b)(6) there was discharge and pus at the surgical wound behind the ear.On (b)(6) 2020 infected granulation tissue was found at the incised part and the implant was exposed through the skin.The device was explanted due to infection on the (b)(6) 2020.

Event Description

The user was implanted in (b)(6) 2020.In the middle of july there was discharge and pus at the surgical wound behind the ear.It was also found at that time that the implant had migrated anteriorly.On (b)(6) 2020 infected granulation tissue was found at the incised part and the implant was exposed through the skin.The device was explanted due to infection on the (b)(6) 2020.

Manufacturer Narrative

Conclusion: 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.This finding was expected because according to the recipient's report the device was explanted due to an infection at the incision with bacteria from the group of staphylococcus aureus and the device was found exposed through skin.Reportedly the recipient was never activated.Further it is reported that the stimulator housing moved from its intended position, which might has contributed to the observed issues.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No new device was implanted.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10710107
• MDR Text Key: 212295665
• Report Number: 9710014-2020-00612
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094027
• UDI-Public: (01)09008737094027
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR