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

Model Number VORP

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

Patient Problems Implant Pain (4561); Insufficient Information (4580)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

The explanted device was received for investigation.

Event Description

The explanted device was received for investigation.According to the explantation report the user was experiencing pain and no hearing benefit with the device.The user never had any benefit with the device.He is still within the indication criteria for the device but did not want to be re-implanted due to the pain he experienced.The pain began several years after implantation and was no longer present once the device was explanted.There was no sign of inflammation or infection at the implant site.The floating mass transducer (fmt) was found to be about 0.5mm from the round window membrane at the time of explantation.The user was not re-implanted.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device malfunction which can explain the reported recipient performance problem.This finding was expected, because according to the recipient report the device was explanted for side effects of otologic surgery, namely pain.Further, it is reported that the recipient never had benefit with the device, which appears to be related to an insufficient mechanical device coupling to the round window.This is a final report.

• 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: 16741233
• MDR Text Key: 313718701
• Report Number: 9710014-2023-00309
• Device Sequence Number: 1
• Product Code: MPV
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Model Number: VORP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 59 YR
• Patient Sex: Male