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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(exemption number e2015033).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
User reported decreased hearing performance following a shunt removal.Fluid is visibly pooled at the base of the recipients neck below the implant.There is however no fluid accumulation over the implant itself.The user's detection levels are unchanged however speech measures are unreliable.
Event or Problem Description
The user reported decreased hearing performance following a spinal shunt removal in (b)(6) 2016.The user was re-implanted.According to information on the device explantation report only 4 working channels were present before explantation.
Additional Manufacturer Narrative
Conclusions: the user reported decreased hearing performance following a spinal shunt removal in (b)(6) 2016.However, the decreased performance was likely not related to the spinal shunt removal, as two affected channels had been observed since (b)(6) 2016 i.E.5 months before surgery.No ct image was performed to confirm the electrode position, but the device explantation report form states that all channels were within the cochlea at explantation.In situ measurements show an increase of affected channels over time and fluctuations with applied pressure.Thus, damage to the active electrode likely caused by device minute mobility is assumed to be the cause of failure.However, the possible electrode damage could not be determined during investigation, as the active electrode was received incomplete.Also, physiological issues might have contributed to the observed abnormal impedance on apical channels.Damages found during investigation are most likely due to the explantation surgery.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: 8432152
• Report Number: 9710014-2019-00234
• Device Sequence Number: 13729228
• Product Code: MCM
• UDI-Device Identifier: 09008737093983
• UDI-Public: (01)09008737093983
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 02/24/2020
• 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: 24 YR