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

Model Number SONATA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Meningitis (2389)

Event Date 10/04/2020

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

Information was received that the device has been explanted due to (cerebrospinal fluid) csf leakage which was observed through the nose and due to meningitis.After the explantation of the device, the surgeon was able to successfully seal the csf gusher.The user was not re-implanted with a new device.

Event Description

Information was received that the device has been explanted on (b)(6)2020 due to meningitis and csf (cerebro-spinal fluid) leakage.After the explantation of the device, the surgeon was able to successfully seal the csf gusher.The user was not re-implanted with a new device.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which might have been present whilst implanted.Reportedly, the concerned device was explanted due to device unrelated medical reasons, i.E.Cerebrospinal fluid leakage (csf) and meningitis.According to the information received, the recipient had recurrent meningitis episodes already prior to implantation for unknown reasons.Thereafter, labyrinthitis ossificans with complete cochlear ossification occurred, which might explain the reported limited benefit.Further, the reported csf rhinorrhea was most likely due to anatomical and surgical reasons, ie.Gusher at implantation.A review of the device_s sterilization records confirms that proper sterilization was applied at the time of manufacturing.No information available points to the implant being the source of infection.During investigation, the device operates within specification.Mechanical damages found during investigation are attributable to the removal surgery.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: 10654557
• MDR Text Key: 210592869
• Report Number: 9710014-2020-00578
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737302283
• UDI-Public: (01)09008737302283
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2020
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 4 YR