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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user was implanted on (b)(6) 2020.At activation on (b)(6) 2020 it was noticed that the implant location was lower than expected.The user returned the following day and complained that the audio processor falls off with basic head movements.The user was to attend a ct scan on (b)(6).A revision surgery is scheduled for (b)(6) to move the implant to a better location.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experiences retention issues with rondo magnet strength #4 and #5 due to an unusual position of the implant.Reportedly the device was initially placed in this position due to the recipient's temporal line and hat wearing.Further it is reported that a full insertion was not achieved at implantation surgery.Currently the recipient is wearing a sonnet 2 with better retention.The recipient will be further monitored.This is a final report.
Event or Problem Description
The user was implanted on (b)(6) 2020.At activation on (b)(6) 2020 it was noticed that the implant location was lower than expected.The user complained that the audio processor falls off and the location of the external device moves with basic head movements.On (b)(6) 2020, the recipient was intubated and anesthetized.The device was palpated and imaged and it was determined that it had not moved from its intended position and had not migrated from the pocket as initially thought.No surgery was performed.As of information received on the 6th august the retention with the sonnet is slightly better with a wear time of around 4 hours a day.The clinic is trying to get the user to increase the wear time before any new plans are made.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10127366
• Report Number: 9710014-2020-00293
• Device Sequence Number: 16667722
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR