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

Model Number MI1200 SYNCHRONY

Device Problem Migration (4003)

Patient Problem Total Hearing Loss (4473)

Event Type  Injury  

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.According to the clinic her hearing scores decreased significantly from 2017 to 2019.Reportedly, the user had lost residual hearing.Additionally, imaging prior to explantation revealed 3 extra-cochlear channels.The user was re-implanted with a flexsoft in order to gain more cochlear coverage with a longer electrode.This report refers to 9710014-2021-00828.For further information please refer to this 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: 12717487
• MDR Text Key: 279026468
• Report Number: 1066702-2021-00089
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310899
• UDI-Public: (01)09008737310899(11)150427(17)170427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2021,10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/28/2021
• Event Location: Other
• Date Report to Manufacturer: 07/28/2021
• 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: 53 YR