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

Model Number SONATA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it 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 had been hearing well until a month ago when she suddenly started hearing long, high-pitched sounds intermittently inside the audio processor (ap).A week later, the sounds turned into a continuous noise, and she felt that the noise was coming from the implant site.At the same time, the recipient began experiencing headaches (in the back of the head) and found it difficult to understand speech.In addition, the high pitched sounds and continuous noise were present even without wearing the ap.Suggestions have been made to consider re-implantation.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the recipient experienced a high-pitched noise with and without the use of the audio processor.Reportedly the recipient is doing well with the new device and the reported symptoms are no longer present.This is a final report.

Event Description

The recipient had been hearing well until a month ago when she suddenly started hearing long, high-pitched sounds intermittently inside the audio processor (ap).A week later, the sounds turned into a continuous noise, and she felt that the noise was coming from the implant site.At the same time, the recipient began experiencing headaches (in the back of the head) and found it difficult to understand speech.The high pitched sounds and continuous noise were present even without wearing the ap.The user has been re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 18208168
• MDR Text Key: 328965778
• Report Number: 9710014-2023-01059
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737042103
• UDI-Public: (01)09008737042103
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: Lay User/Patient
• Device Expiration Date: 05/01/2015
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 16 YR
• Patient Sex: Female