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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Undesired Nerve Stimulation (1980); No Information (3190)
Date of Event	12/13/2018
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
The device has reportedly migrated and a repositioning surgery was discussed.However, as the recipient has never liked the sound quality of the device with the acoustic component it is planned instead to explant this device and re-implant with a +flex28, which is what is on the contra-lateral side.
Additional Manufacturer Narrative
Med-el elektromedizinische geraete (b)(4) and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Conclusions: based on the received information from the field the device was explanted due to movement from its intended position, which was probably caused by the user's habit of rubbing the implant site.In addition, facial nerve stimulation (fns) was observed on various channels and the recipient did not like the sound quality, which could be related to the unavailability of the channels affected by fns.The user's medical history i.E.Trigeminal neuralgia might have contributed to the fns, as the symptom is present also with the new device.The explanted device has not been received for investigational purposes and was possibly lost at the clinic.This is a final report.
Event or Problem Description
The device housing migrated from its original position.In addition, the recipient had facial nerve stimulation on multiple channels (4-5 channels) which was difficult to manage with programming.The user had the habit of rubbing on the implant site, which is thought to be the reason for the housing migration.The recipient was re-implanted on (b)(6) 2019.User was re-implanted mainly due to migration of the housing.A full insertion was confirmed at time of re-implantation.Unfortunately, the clinic cannot locate the explanted device, which at this time is considered as lost.At re-activation with the new device in (b)(6) 2019, the recipient still had facial nerve stimulation on one channel which has been deactivated.The user was otherwise doing well.As per new information from march 2019, facial stimulation was reported again.The recipient reportedly does not wear the processor regularly on the revised side.

• 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: 8188708
• Report Number: 9710014-2018-01032
• Device Sequence Number: 2118291
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 04/09/2019
• 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: 41 YR