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

Model Number SONATA

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/22/2018

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 child was brought in for regular mapping after he was not responding to sounds with the device.There is no history of accident or trauma according to the user's parents.

Manufacturer Narrative

Additional information: according to currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, to determine an exact root cause a device investigation of the explanted device is necessary.No information about possible further steps has been received yet.

Event Description

The user is no longer responding to sounds with the device.There is no history of accident or trauma.No further information has been received.

Manufacturer Narrative

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 recipient report appear to match the damage found.This is a final report.

Event Description

The user is no longer responding to sounds with the device.There is no history of accident or trauma.The user has been re-implanted on (b)(6) 2019.

• 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: 8205901
• MDR Text Key: 131708940
• Report Number: 9710014-2018-01052
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049119
• UDI-Public: (01)09008737049119
• 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,Followup
• Report Date: 12/03/2019

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: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/22/2018; 12/22/2018
• Supplement Dates FDA Received: 02/25/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR