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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vertigo (2134); Dizziness (2194)
Date of Event	01/09/2020
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's hearing performance with the device is affected.The user is experiencing dizziness and loud sounds with the implant.
Event or Problem Description
The user's hearing performance with the device was affected.The user was experiencing dizziness and loud sounds with the implant.The user was travelling in europe in december when the loud sounds started.Prior to the trip, he noticed a gradual decrease in sound quality and performance.On new year's eve he reported that the dizziness and vertigo began, describing a sudden onset that he associated with wearing the processor but also experienced without processor use.The loud sounds are only present when he is wearing the processor.Reportedly, the user had been wearing his device consistently before the problems began.The user will attend routine follow-ups and no further medical intervention is planned.
Additional Manufacturer Narrative
Additional information: according to the received information from the field, the recipient with complex medical history experienced dizziness and loudness issues.Dizziness is a known post-operative side effect of ci implantation.In addition, three channels showed temporarily hi impedance which explains the loudness issues, probably due to physiological issues in the cochlea.However, issues could be resolved by re-fitting and the recipient reports good sound quality.The most basal channel was deactivated due to undetermined reasons.This is a final report.

• 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: 9632130
• Report Number: 9710014-2020-00030
• Device Sequence Number: 502707
• Product Code: MCM
• UDI-Device Identifier: 09008737094010
• UDI-Public: (01)09008737094010
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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: 59 YR