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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and should 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 recipient presented with altered pitch perception and pain when stimulated with high frequencies first on (b)(6) 2018.The problem persisted.Stimulation levels on basal contacts that were acceptable and not painful did not lead to a satisfying hearing.
Additional Manufacturer Narrative
Conclusions: based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem.The investigation showed that the electronic circuit is functional.The recipient_s perception was unsatisfactory and reportedly the maximum acceptable amplitudes without pain during single channel stimulation did not lead to a satisfying hearing in live mode.However, no technical problem could be detected and a still fully inserted electrode array was observed at explantation.The explant report form mentions a medical reason for explantation and re-implantation with another manufacturer's device due to the electrode type.This is a final report.
Event or Problem Description
The recipient reported altered pitch perception, diminished hearing ability and pain when stimulated with high frequencies first on (b)(6) 2018.The problem persisted.Pain occurred when stimulating basal electrode channels.On basal contacts maximum stimulation levels that were acceptable and not painful as found during single channel stimulation did not lead to a satisfying hearing in live mode.On (b)(6) 2018 the recipient was re-implanted with a device from another manufacturer.It was reported that no channels were found extra-cochlear at surgery, as was previously presumed from imaging.Physician confirmed that the reason for the reimplantation was a diminished hearing ability and pain during stimulation of apical and basal electrode contacts.

• 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: 7959718
• Report Number: 9710014-2018-00819
• Device Sequence Number: 1644939
• Product Code: MCM
• UDI-Device Identifier: 09008737078805
• UDI-Public: (01)09008737078805
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: 63 YR