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 Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

It was reported that the ¿pillar extruded, no patient impact.¿ it has been confirmed that the device extruded sometime after the procedure had been completed, and there was no impact on the patient.The date of the initial implantation procedure is unknown.At this time, the patient may have another device implanted in the future.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis could not be performed; device not returned for evaluation.Method: no testing methods performed.

• Brand Name: PILLAR® PROCEDURE SOFT PALATE IMPLANT SYSTEM
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4156830
• MDR Text Key: 4912084
• Report Number: 1045254-2014-00243
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2013
• Device Model Number: PDS3000M
• Device Catalogue Number: PDS3000M
• Device Lot Number: 67609400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Date Device Manufactured: 05/14/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1