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

Model Number MI1210 SYNCHRONY ST

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that the user has a suppurating fistula at the implantation scar area.Reportedly, it was treated by the local ent, however, the user was referred to the clinic in (b)(6) 2023 where a cholesteatoma was diagnosed.It is unclear when the infection started but according to the user there has been leaking purulent material from the fistula for two months and his early care doctor had administered a 10-day treatment with amoxi-clavulanic acid.Cultures were taken and were positive for finegoldia magna, treatment with moxifloxacin was prescribed, which was maintained until (b)(6) , when the fistula was further opened and a recurrence of the cholesteatoma was seen through it, which has been confirmed by pathology after biopsy.The device was explanted on (b)(6) 2023.

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Manufacturer Narrative

Conclusion: device investigation of the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.This finding was expected, because according to the recipient report the device was explanted due to a skin infection over the implant and cholesteatoma.The user has a history of cholesteatoma prior to implantation, which could have contributed to the issue.A review of the devices sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of any infection.This is a final report.

Event Description

It was reported that the user has a suppurating fistula at the implantation scar area.Reportedly, it was treated by the local ent, however, the user was referred to the clinic in (b)(6) 2023 where a cholesteatoma was diagnosed.It is unclear when the infection started but according to the user there has been leaking purulent material from the fistula for two months and his early care doctor had administered a 10-day treatment with amoxi-clavulanic acid.Cultures were taken and were positive for finegoldia magna, treatment with moxifloxacin was prescribed, which was maintained until (b)(6) 2023, when the fistula was further opened and a recurrence of the cholesteatoma was seen through it, which has been confirmed by pathology after biopsy.The device was explanted on (b)(6) 2023.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 17447965
• MDR Text Key: 320281505
• Report Number: 9710014-2023-00664
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male