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); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted but has been disposed of and will not been returned to med-el hq to be evaluated.A device failure analysis based on the information available will be submitted as a follow-up report.

Event Description

The user was not able to detect any sound at the initial activation session.

Manufacturer Narrative

Conclusion: based on initial informtion received it was not clear if the floating mass transducer was positioned properly due to the user having a difficult anatomy.As per additional information it was first attempt at the initial implantation surgery to place the fmt on the stapes which was not possible due to the eroded stapes head and fully fixed step scrurae.It was attemted fixate the fmt on the round window but this was not possible as round window could not be reached.This is a final report.

Event Description

The user was not able to detect any sound at the initial activation session.The device was explanted on (b)(6) 2024.The user received a ci during the same surgery due to the difficult anatomy and borderline for amplification via vsb.

• 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: 18370767
• MDR Text Key: 331057537
• Report Number: 9710014-2023-01134
• Device Sequence Number: 1
• Product Code: MPV
• UDI-Device Identifier: 09008738515460
• UDI-Public: (01)09008738515460
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 12/14/2023
• Date Device Manufactured: 04/23/2023
• 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: 69 YR
• Patient Sex: Female