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 Failure of Implant (1924)

Event Date 08/06/2012

Event Type  malfunction  

Event Description

It was reported that 3 pillar implants were used in the procedure and 2 of these implants extruded within 24 hours of the procedure.

Manufacturer Narrative

(b)(4).The product analysis will not be performed since the device has not been returned for analysis.Methods: no testing methods performed.This device is used for therapeutic purposes.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: sharanya jangiti ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 3985354
• MDR Text Key: 21445864
• Report Number: 1045254-2014-00181
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2014
• Device Model Number: PDS3000M
• Device Catalogue Number: PDS3000M
• Device Lot Number: 0205619252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2012
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2011
• 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: 00044 YR
• Patient Weight: 58