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

Model Number MI1000 MED-EL CONCERT PIN

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The integrity of the skin has broken down.A skin rupture has formed in the area of the implant.The implant housing is visible from the outside.The size of the gap is growing every day and reportedly the skin is thinning from pressure.Imaging shows the implant housing to be located behind the pinna where the hole is.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device defect or problem.This finding was expected, because according to the recipient report the device was explanted for medical reasons, namely a skin breakdown at the implant site caused by repeated traumas.As a consequence infection was seen at the implant site and the implant housing was seen to be exposed through the skin.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.Mechanical damages found during investigation are related to the removal surgery.This is a final report.

Event Description

The implant housing is extruding through the skin.The issues first started in summer of 2019.The user sustained an impact to the head afterwards the user had a short-term edema and slow migration of the device housing closer to the ear was observed.Reportedly the skin was thinning from pressure and dissected after a second impact was sustained.An infection was present, dissection progressed, and the device extruded.The user_s hearing performance with the device was not affected.The user has been explanted on (b)(6), 2020.The infection cleared after explantation.

• 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: 9686725
• MDR Text Key: 178351550
• Report Number: 9710014-2020-00097
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062675
• UDI-Public: (01)09008737062675
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR