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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2019
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
User is reported to have fallen and hit his head after which he lost access to sound with the device.
Additional Manufacturer Narrative
Additional information: the received information from the field indicates a technical problem with the reference electrode.A trauma to the head and complete loss of hearing was reported in may 2019.However, the ground path impedance (gpi) was seen to be increased already prior to the reported trauma due to undetermined reasons.Furthermore it is reported that four channels are extra-cochlea, likely since implantation.To determine an exact root cause, a device investigation would be necessary.The recipient is going to be re-implanted in october 2019.
Event or Problem Description
Recipient is reported to have fallen and hit his head after which he lost access to sound with the device.There was no redness or swelling over the implant site.Reimplantation is scheduled for (b)(6) 2019.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by an external impact, was determined to be the root cause of device failure.Also the active electrode showed some additional damage to the electrode wires.A trauma is mentioned in the recipient's report.Additionally, an incomplete insertion during implantation surgery is reported with 4 channels out of cochlea.The investigation results appear to match the problems mentioned in the recipients report.This is a final report.
Event or Problem Description
It was reported that the recipient fell and hit his head on (b)(6) 2019, after which he lost access to sound with the device.The recipient was re-implanted on (b)(6) 2019.

• 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: 8634916
• Report Number: 9710014-2019-00420
• Device Sequence Number: 13976072
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2020

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
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 05/20/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/25/2019; 01/09/2020
• 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: 9 YR