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

Model Number MI1000 MED-EL CONCERT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2017

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 hearing performance became worse suddenly in (b)(6) 2017.External parts have been checked without improvement.Family reports no incident of accident or trauma.The user was re-implanted on (b)(6) 2017.

Manufacturer Narrative

Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the patient report appear to match the damage found.This is a final report.

Event Description

The hearing performance became worse suddenly (b)(6)2017.External parts have been checked without improvement.Family reports no incident of accident or trauma.The user was re-implanted on (b)(6)2017.

• 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: 7132873
• MDR Text Key: 95318297
• Report Number: 9710014-2017-001041
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737062682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• 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