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 Failure of Implant (1924)

Event Date 08/21/2020

Event Type  Injury  

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.X-ray showed receiver stimulator was placed on bone, but the coil portion was superficial to muscle.The physician thought the device is not seated properly or under the muscle enough.The user had good sound quality and performance with the device.Per patient report, over time the position of the device had shifted inferiorly.Revision surgery took place on (b)(6) 2020.Although it was originally planned to reposition the coil into a new periosteal pocket, the device had to be explanted because the array was pulled from the cochlea, which was confirmed with x-ray.There was also concern that the implant package had additionally been damaged during the reposition attempt, therefore a new device was implanted.

• 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: 10605276
• MDR Text Key: 209129405
• Report Number: 1066702-2020-00067
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020,09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR