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

Model Number MI1200 SYNCHRONY PIN

Device Problem Migration (4003)

Patient Problem Tinnitus (2103)

Event Date 05/10/2021

Event Type  Injury  

Event Description

In the last 4 years the user has made no progress with the device despite programming attempts.He has suffered from tinnitus since surgery with and without use of the device.The severity of the tinnitus is on the same level with the use of the device and without.According to the implant registration card a full insertion was not achieved at implantation, reportedly at least 2 channels were extra-cochlear.The user has been re-implanted.A partial migration of the electrode array out of cochlea was noticed during explantation.This report refers to 9710014-2021-00746.For further information please refer to this 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: 12597323
• MDR Text Key: 281516298
• Report Number: 1066702-2021-00082
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/22/2021,10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/22/2021
• Event Location: Other
• Date Report to Manufacturer: 09/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR