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

Model Number VORP

Device Problems Device Operates Differently Than Expected (2913); Escape (2931)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

Patient reports that he has hearing impressions only during strong jaw movement.Re-implantation is planned for (b)(6) 2015.

Manufacturer Narrative

Conclusion: device investigation revealed damage to the conductive link, likely caused by minute device mobility.The problems described in the patient report appear to match the damage found.Other damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

The patient was at the clinic and reported intermittent hearing impressions, particularly during strong jaw movement.

• 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: 5159240
• MDR Text Key: 28593290
• Report Number: 3004230826-2015-00066
• Device Sequence Number: 1
• Product Code: MPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• 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: 58 YR