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

Model Number MI1200 SYNCHRONY PIN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

In situ measurements showed affected channels on basal portion of array.The recipient was re-implanted.

Event Description

In situ measurements showed affected channels on basal portion of array.Despite requested, no additional information could be retrieved with regards to the concerned device.The recipient was re-implanted in (b)(6) 2018 with a new device, reportedly achieving an incomplete insertion, i.E.2 channels were left extra-cochlear.

Manufacturer Narrative

Conclusion: device investigation did not show any device defect or malfunction which would explain the observed high impedance on the basal channels.Based on available information, it could be assumed that the device was explanted due to a partial electrode array migration out of the cochlea.The investigation results appear to match the problems mentioned in the patient report.This is a final report.

• 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: 8205938
• MDR Text Key: 131730504
• Report Number: 9710014-2018-01055
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR