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

Model Number SONATA

Device Problems Device Appears to Trigger Rejection (1524); Migration (4003)

Patient Problems Skin Tears (2516); No Information (3190)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

Upon observation on (b)(6) 2019, it was noted that the electrode was visible in the external auditory canal.The electrode had extruded.The recipient was re-implanted with a +form19 electrode on (b)(6) 2019.

Manufacturer Narrative

According to the information received from the filed the electrode was visible in the external ear canal.Since reportedly hearing performance with the device was not affected, it is assumed that the electrode lead had extruded into the external ear canal and that the active electrode array was correctly positioned within the cochlea.However, despite requested several times, neither the device nor further information has been received from the field.The recipient was re-implanted.

Event Description

In (b)(6) 2019 it was reportedly noted that the electrode had extruded and was visible in the external auditory canal.Reportedly hearing performance with the device was not affected.No accident or trauma has been reported; no ear cleaning had been performed.The recipient did have benefit from the device at activation.The recipient was re-implanted on (b)(6) 2019.

Manufacturer Narrative

Conclusion: device investigation, on the received parts, did not reveal any device defect or damage which has been present whilst implanted.Damages found during investigation are attributable to the removal surgery.This finding was expected because the device was explanted because the electrode lead extruded into the external ear canal.The investigation results appear to match the symptoms mentioned in the recipient report.This is a final report.

Event Description

In (b)(6) 2019 it was noted that the electrode had extruded and was visible in the external auditory canal.No accident or trauma has been reported; no ear cleaning had been performed.Hearing performance with the device was not affected.The recipient did have benefit from the device at activation.The recipient was re-implanted on (b)(6) 2019.

Manufacturer Narrative

Correction: in this follow-up 3 the date of device received was corrected.

Event Description

This is a correction to follow-up report #2.The date of device received was incorrect.The correct date is 04-oct-2019, not 07-feb-2020 as was erroneously given in follow-up 2.

• 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: 8490841
• MDR Text Key: 141170264
• Report Number: 9710014-2019-00301
• 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,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• 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: 10/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR