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

Model Number SONATA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 12/19/2017

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

Patients hearing with the device is affected. As per the parents of the patient no trauma had occured. It is reported that the xray shows full insertion. External parts have been checked. Re-implantation is considered.

Manufacturer Narrative

Additional information: according to the 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. Re-implantation is being considered, but no surgery date has been communicated.

Event Description

Recipient_s hearing with the device has been affected. As per the parents of the recipient no trauma has occurred. Re-implantation is considered but no date has been scheduled yet.

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

Event Description

Recipient's hearing with the device has been affected. As per the parents of the recipient no trauma has occurred. The user has been 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: 7141525
• MDR Text Key: 95665495
• Report Number: 9710014-2017-001095
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: EG
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/22/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: SONATA
• OTHER Device ID Number: (01) 09008737083618
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/19/2017
• 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 TREATMENT DATA

Date Received: 12/22/2017 Patient Sequence Number: 1