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 Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	03/18/2019
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
Recipient was seen for mapping and no responses were noted with the right side device.No recent illnesses, injuries, or head trauma was reported.
Event or Problem Description
Recipient was seen for mapping and no responses were noted with the right side device.No recent illnesses, injuries, or head trauma was reported.Device was explanted on (b)(6) 2019, no new device was implanted since during explantation pockets of infection surrounding the device were encountered.The lead was cut and left in the cochlea.Re-implantation was postponed allowing the tissue to heal and will be performed after complete recovery in several months.
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.Other damages found during investigation are most likely related to the explantation surgery.Furthermore, during explantation soft tissue and deep tissue infection along the incision line was encountered.Re-implantation is considered after the recipient has recovered from the infection.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: 8489971
• Report Number: 9710014-2019-00295
• Device Sequence Number: 1664661
• 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: 2018
• 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): 09/11/2019

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: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: 27 MO