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

Model Number MI1250 SYNCHRONY 2

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The recipient is not responding with the device, and has had increasing/fluctuating number of high impedance channels since activation.

Manufacturer Narrative

Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.Other damages found during the device investigation are attributable to the explantation surgery.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The recipient was not responding with left device and has had increasing/fluctuating number of channels with high impedance since activation.Neither changes in health nor head trauma or accident were reported.The user was re-implanted on the (b)(6) 2020.

• 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: 10625352
• MDR Text Key: 209780658
• Report Number: 9710014-2020-00552
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827(11)200120(17)230120
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO