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

Model Number VORP

Device Problems Migration or Expulsion of Device (1395); No Audible Prompt/Feedback (2282); Cut In Material (2454); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Event Description

The patient underwent revision surgery due to no sound responses during audiogram measurements.The floating mass transducer was found out of middle ear and migrated into the mastoid.As the conductor link was accidentally cut, the damaged vorp was explanted and a back-up device re-implanted.

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

Conclusion: based on the information received the reported problems was related to an insufficient mechanical fmt coupling to the round window.During the revision surgery the conductive link was inadvertently cut, so it was necessary to replace the device.Device has not been received for investigation as it had been disposed by the clinic.This is a final report.

Event Description

The patient underwent revision surgery due to no sound responses during audiogram measurements.The floating mass transducer was found out of middle ear and had migrated into the mastoid.As the conductor link was accidentally cut, the damaged vorp was explanted and a back-up device re-implanted.The explanted device was disposed of by the clinic and is not available for investigation.

• 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: 4911603
• MDR Text Key: 6014966
• Report Number: 3004230826-2015-00039
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VORP
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 68 YR