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

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

The user is unable to wear the bte processor due to its close proximity to the receiver/stimulator.Therefore, it is planned to move the receiver more posteriorly and superiorly.It is unclear if the stimulator has moved from the initial placement.The surgery for re-positioning is scheduled for (b)(6) 2023.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.Note: the age of the recipient is unknown.

Manufacturer Narrative

Additional information: according to the information received from the field the recipient underwent a re-positioning surgery of the implant housing because it was too close to the audio processor.The re-positioning was successfully performed.The device remains implanted and in use.This is a final report.

Event Description

The user is unable to wear the bte processor due to its close proximity to the receiver/stimulator.Therefore, it is planned to move the receiver more posteriorly and superiorly.It is unclear if the stimulator has moved from the initial placement.The surgery for re-positioning took place on (b)(6) 2023.

• 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: 16793840
• MDR Text Key: 313809675
• Report Number: 9710014-2023-00340
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 06/19/2023
• Date Device Manufactured: 09/28/2022
• 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: 75 YR
• Patient Sex: Male