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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
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
Recipient reported no sound from his processor while watching tv.There were no additional strange sounds or unusual auditory perceptions.
Event or Problem Description
Recipient reported no sound from his processor while watching tv around (b)(6) 2019.There were no strange sounds or unusual auditory percepts prior to this and it occurred suddenly.There was no report of an accident or trauma, no changes in health or swelling at the implant site reported.Re-implantation was decided after an unremarkable medical assessment.The recipient was re-implanted on (b)(6) 2019.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.Furthermore in situ measurements show two channels with hi status and other electrodes with increased impedances since (b)(6) 2015 due to undetermined reasons.Other damages found during investigation are attributable to the removal surgery.The problems given in the recipient report appear to match the damage found.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: 8956991
• Report Number: 9710014-2019-00655
• Device Sequence Number: 14105642
• Product Code: MCM
• UDI-Device Identifier: 09008737062699
• UDI-Public: (01)09008737062699
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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: 6 YR