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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	Head Injury (1879)
Type of Reportable Event	Malfunction
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 child fell on the stairs and hit his head on the iron railing of the stairs.
Additional Manufacturer Narrative
Additional information: based on the received information, damage to the active electrode due to the reported trauma appears very likely.However to determine an exact root cause a device investigation would be necessary.Reportedly the recipient is satisfied with the hearing performance.The device remains implanted and in use.
Event or Problem Description
The child fell on the stairs and hit his head on the iron railing of the stairs.

• 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: 11300283
• Report Number: 9710014-2021-00081
• Device Sequence Number: 3368665
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2021
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR