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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
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
The recipient's hearing performance with the device has decreased between 6 and 12 months post-activation.He reports intermittencies in sound and his ability to understand speech fluctuates.No incident of accident or trauma is reported.Re-implantation has been scheduled.
Additional Manufacturer Narrative
Med-el elektromedizinische geraete gmbh and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The investigation results appear to match the problems mentioned in the recipient report.This is final report.
Event or Problem Description
The recipient's hearing performance with the device has decreased between 6 and 12 months post-activation.He reports intermittencies in sound and his ability to understand speech fluctuates.No incident of accident or trauma is reported.The recipient was re-implanted.

• 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: 7800539
• Report Number: 9710014-2018-00648
• Device Sequence Number: 228840
• 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: 2017
• Device Explanted 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): 11/13/2018

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: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 71 YR