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 Codes	Failure of Implant (1924); Undesired Nerve Stimulation (1980); Tinnitus (2103)
Date of Event	11/26/2018
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
The user experienced a sudden loss of sound with the device.In the following few days the device would work intermittently.On the third day, after 3-4 hours of use, he had an uncomfortable pinching feeling in his ear and facial nerve stimulation.This was followed by a tinnitus that changed from high pitched to low pitched.No trauma or accident is reported.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The problems given in the recipient report appear to match the damage found.The reported tinnitus and facial nerve stimulation are known post-operative side effects of ci implantation.Other mechanical damages found during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
The recipient experienced a sudden loss of sound with the device.In the following few days the device would work intermittently.On the third day, after 3-4 hours of use, he had an uncomfortable pinching feeling in his ear and facial nerve stimulation.This was followed by a tinnitus that changed from high pitched to low pitched.No trauma or accident is reported.The user has been reimplanted.

• 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: 8132359
• Report Number: 9710014-2018-00983
• Device Sequence Number: 18877800
• Product Code: MCM
• UDI-Device Identifier: 09008737062736
• UDI-Public: (01)09008737062736
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 07/15/2019

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: 07679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 07/15/2019
• 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: 24 YR