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

Model Number PDS3000M

Device Problem Extrusion (2934)

Patient Problem Failure of Implant (1924)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: no analysis results available; the device was not returned for evaluation.Note: per the instructions for use: potential complications: use of the system involves potential risks normally associated with the use of any implanted device, including but not limited to, those listed below: difficulty swallowing, erosion of implant, gastro-intestinal obstruction, implant aspiration, implant rejection, implant migration, infection, mucosal edema, partial/full extrusion of implant, sore or scratchy throat, voice/taste change, allergic reaction to implant material, foreign body sensation.

Event Description

It was reported that 2 out of the 3 pillars initially implanted had partially extruded.The patient had them completely removed during an office visit, and is scheduled to have them replaced.There was no patient impact or injury.

Manufacturer Narrative

Age at event: (b)(6).Date of this report: 09/09/2016.Describe event problem: additional information received: the patient underwent surgery on (b)(6) 2016, to have the 2 pillar devices re-implanted.¿the procedure took place with no complications during the inserting, so we are seeing the patient again in follow up (b)(6) 2016, unless issues happen prior to this date.¿ date manufacturer received: 10/04/2016.

Event Description

Additional information received: the patient underwent surgery on (b)(6) 2016, to have the 2 pillar devices re-implanted."the procedure took place with no complications during the inserting, so we are seeing the patient again in follow up (b)(6) 2016, unless issues happen prior to this date.".

Manufacturer Narrative

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

• Brand Name: PILLAR® IMPLANT
• 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 dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 5996572
• MDR Text Key: 56373771
• Report Number: 1045254-2016-00323
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: PDS3000M
• Device Catalogue Number: PDS3000M
• Device Lot Number: 0208301723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2014
• 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: 57 YR