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

Model Number SONATA

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/25/2017

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

Decrease in the patients hearing performance with the device. An accident/trauma was reported.

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. Currently no information was made available on further steps.

Event Description

There was a decrease in the recipient's hearing performance with the device. No trauma was reported. No further information has been made available.

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

There was a decrease in the recipient's hearing performance with the device. No trauma was reported. 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
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 7153784
• MDR Text Key: 96022730
• Report Number: 9710014-2017-01120
• 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: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/29/2017
• 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) 09008737049119
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/20/2019

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/25/2017
• 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: 12/29/2017 Patient Sequence Number: 1