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

Model Number MI1200 SYNCHRONY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 audiologist reported that initially sound quality with the device changed dramatically and then the recipient lost auditory percept on the higher frequency electrode channels.A decline in performance could not be determined as the decrease in sound quality was noted at the first post-op assessment.Neither accident or trauma, nor changes in health were reported.The patient is scheduled for revision surgery.

Manufacturer Narrative

(b)(4) and vibrant (b)(4) submit mdr reports on behalf of (b)(4) corporation (exemption number (b)(4)).According to the information received, the device was not providing benefit to the patient due to a post-operative active electrode migration out of cochlea, as confirmed by post-operative diagnostic imaging.A full insertion was achieved at initial implantation.A surgery to re-insert the electrode was successfully performed.The concerned device remains implanted and in use.

Event Description

The recipient lost auditory percept on the higher frequency electrode channels.A decline in performance could not be determined as the decrease in sound quality was noted at the first post-op assessment.A revision surgery has been performed.

• 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: 7147191
• MDR Text Key: 95790255
• Report Number: 9710014-2017-01104
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737094041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR