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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932)
Date of Event	10/25/2019
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
Since implantation, the patient hasn't shown any clear advancements with the device.On (b)(6) 2019, a small bump was seen over her scar.According to ent, a tumor at the region was found with 8mm in diameter with no inflammation processes.It is painful on palpation.The user refuses to use the device.No incident of accident or trauma was reported.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient experienced pain when using the audioprocessor caused by tumoration which developed at the implant site.A revision surgery was performed.It was noticed that part of the flap suture was accidentally left in place for a prolonged period of time after implantation surgery, leading to an inflammatory reaction in response to the retained material that is also known as suture granuloma.Although the latter may mimic a tumor, it represents a benign formation.Non-absorbable sutures should be removed within 1-2 weeks of their placement.Such prompt removal reduces the risk of suture infection and tissue reaction.Reportedly the recipient is doing fine after revision surgery.The device remains implanted and in use.This is a final report.
Event or Problem Description
Since implantation, the recipient hadn't showed any clear advancement with the device.There was no clear response to the device according to rehabilitation information.On (b)(6)2019 a small bump was seen over her scar.The recipient underwent a revision surgery on (b)(6) 2019.Reportedly, the recipient was re-activated with good results.

• 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: 9279043
• Report Number: 9710014-2019-00849
• Device Sequence Number: 336218
• Product Code: MCM
• UDI-Device Identifier: 09008737062736
• UDI-Public: (01)09008737062736
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 06/04/2020
• 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: 3 YR