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

Model Number MI1200 SYNCHRONY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

In (b)(6) 2016, the patient had an implant bed revision due to a skin defect and exposed device.It is unknown if the surgical wound healed completely after this surgery.Magnet strength of the external device was also reduced in 2016, which reportedly alleviated the pain some.The patient was explanted on (b)(6) 2017 due to a skin infection and extrusion of the device, per explantation report.The problem reportedly started in (b)(6) 2017.Cultures were taken, but results are unknown.Patient was treated with intensive antibiotic and local therapy.The patient had hearing benefit from the device and there is no allegation against the device.

Manufacturer Narrative

Conclusion: device investigations of the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.During investigation the device operates within specification.This finding was expected, because according to the recipient's report the device was explanted for medical reasons, namely skin infection which led to implant extrusion.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.Also, external device's magnet strength was reduced in 2016 due to pain and implant bad revision was conducted the same year, pointing to a recurrent issue.Damage found during investigation is most likely related to the removal surgery.This is a final report.

Event Description

In (b)(6) 2016, the recipient had an implant bed revision due to a skin defect and exposed device.It is unknown if the surgical wound healed completely after this surgery.Magnet strength of the external device was also reduced in 2016, which reportedly alleviated the pain for some time.The recipient was explanted on (b)(6)-2017 due to a skin infection and extrusion of the device, as per explantation report.The problem reportedly started in (b)(6) 2017.Recipient was treated with intensive antibiotic and local therapy beforehand.Further plans for a new device are unknown.

• 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: 7127974
• MDR Text Key: 95161843
• Report Number: 9710014-2017-01073
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

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
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737094041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/23/2017
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 69 YR