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 Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
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
User reported a decreased in hearing performance with the device following a car accident on the the (b)(6) 2019.The user was hit hard from behind resulting in swelling over the face.She was also treated by the er for a middle ear infection.
Additional Manufacturer Narrative
Med-el elektromedizinische geraete gmbh and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Additional information: according to the received information from the field the recipient experienced a temporary loss of hearing after a head trauma.Reportedly in-situ measurements could not be obtained as no communication between internal and external device was possible, which was likely related to the reported swelling.As per latest information, the swelling has resolved the recipient hearing performance is good again.Further, in situ measurements show a fully functional device with all channels working within normal limits.Therefore the device remains implanted and in use.
Event or Problem Description
User reported a decreased in hearing performance with the device following a car accident on the in (b)(6) 2019.The user was hit hard from behind resulting in swelling over the face.She was also treated for a middle ear infection.As per new information, user's hearing performance is currently good following the resolution of the swelling.

• 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: 8489963
• Report Number: 9710014-2019-00292
• Device Sequence Number: 16589612
• Product Code: MCM
• UDI-Device Identifier: 09008737062736
• UDI-Public: (01)09008737062736
• 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): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR