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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/14/2021
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
The user suffered from a persistent infection over the left implant.According to study data, an adverse event was reported for redness and drainage from the left incision on (b)(6) 2021 (nine days after implantation) that resolved on (b)(6) 2021 with amoxicillin and mupirocin.On the (b)(6) 2021 swelling was reported.On (b)(6) 2021 the users mother reported redness with no fever.Antibiotics were prescribed and it was recommended not to wear the processor.The surgical incision was intact and the skin closed.The recipient had a type b tympanogram late after surgery and was concerning for possible otitis media.Medical records indicate a type b (flat) tympanogram on (b)(6) 2021, thus consistent with fluid or potential otitis media in the middle ear.Later incision and drainage was performed on (b)(6) 2021 and the user was treated with augmentin to treat the fluid collection in the left postauricular area.Preliminary lab results of cultured fluid revealed methicillin resistant staphylococcus aureus (mrsa), and the clinic started treatment with bactroban topical ointment on (b)(6) 2021.
Additional Manufacturer Narrative
Conclusions: device investigation did not reveal any device defect or damage, which is assumed to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the recipient suffered from re-occurring infection at the surgical incision, which initially occurred nine days after implantation surgery.A review of the device devices sterilization records shows that the device has been subjected to a valid sterilization process.This is a final report.
Event or Problem Description
The user suffered from a persistent infection over the left implant.Explantation took place on (b)(6) 2021.The device housing was found in place and electrode array fully inserted.

• 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: 12047842
• Report Number: 9710014-2021-00459
• Device Sequence Number: 3427240
• Product Code: MCM
• UDI-Device Identifier: 09008737366773
• UDI-Public: (01)09008737366773
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: 12 MO