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 Problems Undesired Nerve Stimulation (1980); Injury (2348); No Information (3190)

Event Date 01/18/2019

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 recipient was bilaterally implanted on (b)(6) 2019.Post-operatively he has been found to have a facial nerve injury for the right side.He is planned to undergo an exploration with possible nerve repair in (b)(6) 2019.The clinic is planning to remove the device and replace it during the surgery.

Manufacturer Narrative

Med-el elektromedizinische geraete gmbh and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Conclusion: according to the received information from the field, the recipient suffered from a facial nerve paralysis after implantation; facial nerve injury is a known possible surgical complication of cochlear implantation.A revision surgery was carried out to repair the facial nerve, but the partial facial paralysis is reportedly still present afterwards.Also, during this procedure the electrode array was accidentally pulled out of cochlea and re-inserted straight again.Despite the facial nerve issue, the recipient is hearing and progressing well and the device remains implanted and in use.This is a final report.

Event Description

The recipient was bilaterally implanted on (b)(6) 2019.Post-operatively a facial nerve injury has been found for the right side.An exploratory surgery to repair the facial nerve was performed in february 2019.The symptoms relating to facial nerve injury are still present after the revision surgery.As per audiologist, recipient still has observable partial facial paralysis.Device has been activated and recipient is hearing and progressing well.Audiologist confirmed that recipient appears to receive sound percepts along the whole array.

• 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: 8320919
• MDR Text Key: 135539085
• Report Number: 9710014-2019-00117
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• 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
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 MO