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

Model Number MI1200 SYNCHRONY

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

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 recipient was seen at the audiologist as he no longer had hearing sensation with the device.There is no report of accident or trauma.

Manufacturer Narrative

Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The recipient was seen at the audiologist as he no longer had hearing sensation with the device.There is no report of accident or trauma.There have been no changes in health or medication.The recipient was re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 8205923
• MDR Text Key: 131709131
• Report Number: 9710014-2018-01053
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310844
• UDI-Public: (01)09008737310844
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 8 YR