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

Model Number MI1200 SYNCHRONY

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 08/21/2020

Event Type  Injury  

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 Description

The user has been experiencing persistent pain/soreness around the implant site, which is worse when smiling or moving the muscles around the site.This problem has been happening since implantation.The user had good sound quality and performance with the device.Per patient report, over time the position of the device had shifted inferiorly.The user was re-implanted.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage which has been present whilst implanted.Mechanical damages found during device investigation are attributable to the removal surgery.According to the information received from the field the recipient experienced pain and discomfort since implantation, which were most likely caused by a migration of the implant from its intended position.A re-positioning surgery was performed.However during the surgical intervention the electrode array was accidentally pulled out of cochlea.Therefore, the device was explanted and a back-up device was implanted.This is a final report.

Event Description

The user has been experiencing persistent pain/soreness around the implant site, which was worse when smiling or moving the muscles around the site.This problem has been happening since implantation.X-ray showed receiver stimulator was placed on bone, but the coil portion was superficial to muscle.Per patient report, over time the position of the device had shifted inferiorly.The user had good sound quality and performance with the device.Revision surgery took place on (b)(6) 2020.

• 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: 10599364
• MDR Text Key: 208943260
• Report Number: 9710014-2020-00553
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041(11)190205(17)220205
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR