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

Model Number MI1200 SYNCHRONY

Device Problems Output Problem (3005); Migration (4003)

Patient Problems Failure of Implant (1924); Vertigo (2134)

Event Date 06/20/2019

Event Type  Injury  

Event Description

The audiologist expressed concern over affected channels.At activation in (b)(6) 2019 channels 11 and 12 were disabled and at follow-up channels 9 and 10 were additionally disabled due to severe vertigo with stimulation.The user was getting benefit from the device.Ct scan confirmed extra-cochlear channels.Surgery took place on (b)(6) 2019.At least three contacts were found extra-cochlear.It was attempted to re-insert the array, but the array could not be advanced any further.Therefore a new device with a shorter electrode array was implanted.This report refers to 9710014-2019-00675.For further information please refer to this 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: 9001344
• MDR Text Key: 160442291
• Report Number: 1066702-2019-00011
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2019,09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2019
• Event Location: Other
• Date Report to Manufacturer: 09/03/2019
• 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: 81 YR