MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VIBRANT SOUNDBRIDGE; MIDDLE EAR IMPLANT

Model Number VORP 503

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

The user was implanted (b)(6) 2023 and the device was switched-on (b)(6) 2023.The user has a samba 2 lo left audio processor (ap).The device worked for the first two weeks before it stopped.

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.

Manufacturer Narrative

According to the information received from the field the recipient experienced a decrease in hearing performance.Reportedly the recipient was re-fitted and the expected level of benefit has been achieved.The recipient will be monitored by the clinic.The device remains implanted and in use.This is a final report.

Event Description

The user was implanted (b)(6) 2023 and the device was switched-on (b)(6) 2023.The user has a samba 2 lo left audio processor (ap).The device worked for the first two weeks before it stopped.A new ap was sent out but she reported that there was still no sound.As per information from november 2023 the recipient is wearing the device consistently and is getting the expected level of benefit from it.

• Brand Name: VIBRANT SOUNDBRIDGE
• Type of Device: MIDDLE EAR 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: 17276620
• MDR Text Key: 318572474
• Report Number: 9710014-2023-00575
• Device Sequence Number: 1
• Product Code: MPV
• UDI-Device Identifier: 09008738515460
• UDI-Public: (01)09008738515460
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990052
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VORP 503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Date Device Manufactured: 11/23/2022
• 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 Age: 23 YR
• Patient Sex: Female