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

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The device is thought to have migrated post-operatively.A post-operative scan performed on the (b)(6) 2020 showed incomplete insertion with only 4 electrodes within the cochlea.The user was successfully re-implanted on the (b)(6) 2020.

Manufacturer Narrative

Additional information: according to the received information from the field, the active electrode array migrated almost completely out of cochlea post-operatively.Reportedly, multiple insertion attempts were made at implantaton and during re-insertion surgery the electrode was inadvertently damaged, thus affected channels were seen and re-implantation with a new device was carried out at a later point in time.The explanted device has not been received for investigation yet.

Event Description

The recipient was implanted on the (b)(6) 2020.At implantation there were multiple attempts to insert via round window, then a cochleostomy was drilled and widened and the electrode was inserted.The device is thought to have migrated post-operatively.At a re-positioning surgery the array was reportedly damaged.The recipient was re-implanted with a new device on the (b)(6) 2020.Despite requested, the explanted device has not been not received for investigation.

• 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: 10710106
• MDR Text Key: 212284337
• Report Number: 9710014-2020-00611
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR