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

Device Problem Human-Device Interface Problem (2949)

Patient Problem Hearing Loss (1882)

Event Date 06/23/2015

Event Type  Injury  

Manufacturer Narrative

Na.Conclusion: device investigation did not reveal any device defect which is expected to have been present whilst implanted.According to the patient report, the patient was no longer in the audiological criteria for the vibrant soundbridge and has been re-implanted with a cochlear implant.This is combined initial and final report.

Event Description

The patient was explanted of the vorp as the patient's hearing dropped due to progredient hearing loss to such an extent that the patient was no more in the indication criteria of the vibrant soundbridge.

• 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-60-20 ; AU A-6020 ; 6460705562
• MDR Report Key: 5003709
• MDR Text Key: 23124844
• Report Number: 3004230826-2015-00050
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• 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: 67 YR