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

Model Number VORP

Device Problems Device Inoperable (1663); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported that the pt was explanted on (b)(6) 2014 due to device malfunction.

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

Device investigations did not reveal any device defect on the available portion of the device, which is expected to have been present whilst implanted.Despite several requests, no further information has been received.Due to the lack of valuable information, it was not possible to identify a root cause of failure during the case investigation.This is a final report.

Event Description

It was reported that the patient was explanted of the vibrant soundbridge on (b)(6) 2014 due to a device malfunction.No further information was received from the explanting clinic despite several requests.

• 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: 4462292
• MDR Text Key: 5319574
• Report Number: 3004230826-2015-00003
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• 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: 01/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• 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: 45 YR