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

Model Number MI1200 SYNCHRONY PIN

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 01/23/2019

Event Type  Injury  

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

The recipient was bilaterally implanted.On activation, it was observed that the left electrode lead was exposed and blood could be seen in the left external auditory canal.Ct imaging is awaited to confirm the electrode position on the left side.

Manufacturer Narrative

Additional information: according to the received information, temporary symptoms observed during the first activation attempt were most likely related to complications derived from the surgical technique required during implantation.Additionally, a complete insertion could not be achieved at implantation with postoperative diagnostic imaging indicating an additional partial electrode migration outside of the cochlea.However, the user could be successfully activated with the remaining electrodes.The device remains implanted and in use.No further intervention is considered.

Event Description

The recipient was bilaterally implanted.During activation, it was observed that the concerned left device electrode lead was exposed, and blood could be seen in the left external auditory canal.Only the contralateral device was activated, being the concerned left device activation postponed.As per latest information received, the user was activated without any problems.Everything worked correctly during the fitting session.No further intervention is planned.

• 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: 8300868
• MDR Text Key: 134857995
• Report Number: 9710014-2019-00094
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737093969
• UDI-Public: (01)09008737093969
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• 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: 31085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 MO