MAUDE Adverse Event Report: VIBRANT MED-EL HEARING TECHNOLOGY GMBH VIBRANT SOUNDBRIDGE; VORP

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the patient was re-implanted on (b)(6) 2015, with a new vorp due to sudden dysfunction.Imaging performed prior to device explantation showed the vibrant soundbridge in place.

Manufacturer Narrative

The device has been explanted and should be returned to the mfr for evaluation.When available, a device failure analysis will be submitted as a f/u report.

• Brand Name: VIBRANT SOUNDBRIDGE
• Type of Device: VORP
• Manufacturer (Section D): VIBRANT MED-EL HEARING TECHNOLOGY GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4510195
• MDR Text Key: 5487960
• Report Number: 3004230826-2015-00009
• Device Sequence Number: 1
• Product Code: MPV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• 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: 34 YR