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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The explanted device was received for investigation.According to the explantation report the user no longer had hearing sensation.The user was not re-implanted with any device.

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.According to the explantation report the user no longer had hearing sensation.The user was not re-implanted with any device.

Manufacturer Narrative

Conclusions: device investigations did not reveal any device defect present whilst implanted.Mechanical damages found are attributable to the removal surgery.This finding was expected, because according to the recipient report the device was found to be functional whilst implanted.Therefore, it is assumed that the explantation was not related to the implant but to the selection criteria.The recipient was not a good candidate for the device because the user was preoperatively out of the indication criteria.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: 16635601
• MDR Text Key: 312217311
• Report Number: 9710014-2023-00261
• Device Sequence Number: 1
• Product Code: MPV
• UDI-Device Identifier: 09008738515460
• UDI-Public: (01)09008738515460
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: 70 YR
• Patient Sex: Male