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

Model Number SONATA

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problems Ossification (1428); Head Injury (1879); Failure of Implant (1924)

Event Type  malfunction  

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

One month ago (approximately (b)(6) 2020) the user was hit on the head with a ball.Ten days after this incident she was no longer able to hear with the device.

Manufacturer Narrative

Additional information: according to the information received from the field the recipient experienced a loss in hearing performance ten days after a head trauma.In situ measurements showed increased impedance values and an increased ground path impedance.However the electrodes seem not to be damaged.Based on the available information, currently a root cause cannot be determined.Re-implantation is considered but no date has been scheduled yet.

Event Description

In may 2020 the user was hit on the head with a ball.Ten days after this incident she was no longer able to hear with the device.

• 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: 10275173
• MDR Text Key: 198866647
• Report Number: 9710014-2020-00377
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737042189
• UDI-Public: (01)09008737042189
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR