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

Model Number MI1200 SYNCHRONY

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Total Hearing Loss (4473)

Event Type  Injury  

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.

Event Description

Reportedly, the clinic received a registration for a synchrony 2 flex soft (sn (b)(4)) which documented that synchrony flex24 (sn (b)(4)) had been explanted.They have received no prior notification of any issue from the surgeon or clinic.The user had lost residual hearing resulting in poor performance with the device.

Event Description

Reportedly, the clinic received a registration for a synchrony 2 flex soft (sn (b)(6) which documented that synchrony flex24(sn (b)(6) had been explanted.They have received no prior notification of any issue from the surgeon or clinic.According to the clinic her hearing scores decreased significantly from 2017 to 2019.Reportedly, the user had lost residual hearing.The user was re-implanted with a flexsoft in order to gain more cochlear coverage with a longer electrode.

Manufacturer Narrative

Conclusion: device investigations 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 patient report the recipient, who was implanted with a flex24 electrode, lost residual hearing due to undetermined reasons.In addition, the active electrode migrated postoperatively out of cochlea as confirmed by post-operative imaging.The recipient has been re-implanted with a longer electrode type.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 12711233
• MDR Text Key: 278772210
• Report Number: 9710014-2021-00828
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310899
• UDI-Public: (01)09008737310899
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2017
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR