MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PILLAR® PROCEDURE SOFT PALATE IMPLANT SYSTEM; DEVICE, ANTI-SNORING

Model Number PDS3000M

Device Problem Extrusion (2934)

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

Event Date 06/07/2014

Event Type  malfunction  

Event Description

The patient¿s mother reported that her son completed the pillar implant procedure in (b)(6) 2013.Three pillars were implanted during that time.It is reported over the past 6 weeks the patient has experienced one of the pillars feeling loose and traveling around at the implant site.He reported feeling like it was coming out.He is currently living in texas so he called his physician for information on what he should do.He was advised to go to an emergency care facility and they would take care of it.The patient has tried several emergency care facilities and ent specialists with no success as no one would touch the device.He was given antibiotics and sent home.On saturday (b)(6) 2014 the patient felt it was so loose he sterilized a pair of tweezers, tugged on the device, and it slid right out.There was no pain or bleeding reported.He took the antibiotics prescribed.The other 2 pillars remain implanted and have given no trouble to the patient.

Manufacturer Narrative

(b)(4).The device has not been returned.Therefore, an analysis has not been performed.Method: actual device not evaluated.This device is used for therapeutic purposes.

• Brand Name: PILLAR® PROCEDURE SOFT PALATE IMPLANT SYSTEM
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 3908121
• MDR Text Key: 19479856
• Report Number: 1045254-2014-00141
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K040417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PDS3000M
• Device Catalogue Number: PDS3000M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2014
• 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 Age: 00025 YR