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 10/02/2014

Event Type  malfunction  

Event Description

It was reported that during device follow-up, the patient ¿noted a foreign body coming out of his palate.¿ the doctor recommended explanting the device to prevent palate cellulitis, but not serious injury or death.The device was extracted.There was no patient impact.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.

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 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: 4199069
• MDR Text Key: 5149934
• Report Number: 1045254-2014-00267
• 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,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2016
• Device Model Number: PDS3000M
• Device Catalogue Number: PDS3000M
• Device Lot Number: 0207101890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2013
• 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: 00071 YR