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

Model Number MI1200 SYNCHRONY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

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 implant was activated in (b)(6) 2018 and at the beginning the user had very good hearing performance.In (b)(6) 2019 the user reported a little pain at the implant site and had her magnet changed from #4 to #3.The user came back in (b)(6) 2019 and was hospitalized because of terrible pain at the implant side.Use of audio processor was stopped and a therapy with antibiotics and cortisone was started.Even after two weeks the pain did not subside.The recipient suffered even when the coil was near the skin but not in touch with it and when the implant site was touched with the hand.The device was explanted in (b)(6) 2019.At explantation the device was wrapped in a biofilm.The electrode array was left implanted for re-implantation at a later date.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage which has been present whilst implanted.According to the information received, the recipient experienced delayed pressure pain at the implant site, which was perceptible even when the external magnet and processor were not used and did not subside with conservative treatment.No signs of infection or inflammation have been reported.At explantation, a biofilm was suspected, however it was not confirmed.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.Damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

The implant was activated in (b)(6) 2018 and at the beginning the user had very good hearing performance.In may 2019 the user reported a little pain at the implant site and had her magnet changed from #4 to #3.The user came back in (b)(6) 2019 and was hospitalized because of terrible pain at the implant side.Use of audio processor was stopped and a therapy with antibiotics and cortisone was started.Even after two weeks the pain did not subside.The recipient suffered even when the coil was near the skin but not in touch with it and when the implant site was touched with the hand.

• 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: 9327709
• MDR Text Key: 166581232
• Report Number: 9710014-2019-00882
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• UDI-Public: (01)09008737094003
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR