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

Model Number SONATA

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Tissue Damage (2104)

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 recipient has been explanted on (b)(6) 2019.No information about the cause of the explant surgery nor problems related to the device were provided.

Event Description

The recipient has been explanted on (b)(6) 2019.According to the device explant report form the device partially extruded through the skin scar; also reportedly the electrode was out of the cochlea.The user had a wound prior to the extrusion.The magnet strength cannot be ruled out as a possible cause.The original surgical wound healed properly.

Manufacturer Narrative

Device investigation did not reveal any device defect or damage which has been present whilst implanted.This finding was expected because the device was explanted due to a partial extrusion of the implant housing through the skin.Reportedly a wound was present before the extrusion and contribution of the magnet strength cannot be ruled out.Furthermore information on the device explantation report form states that the electrode array was outside of cochlea at the time of explantation.A complete insertion was reportedly achieved at initial implantation.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: 8564721
• MDR Text Key: 143549346
• Report Number: 9710014-2019-00355
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• UDI-Public: (01)09008737083618
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR