MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC13; ANTI-REFLUX IMPLANT

Catalog Number LXC13

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 03/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 4516 was reviewed.No ncs, reworks, or defects were found.Diagnosed with gerd defined by abnormal ph testing: yes.Chronic gerd symptoms despite maximum medical therapy for treatment of reflux: yes.Ph test performed (b)(6) 2013.Date ppi stopped (b)(6) 2013.Method used: bravo capsule.Duration of test: 48 hours.Test duration: 1 day, 23 hours, 51 minutes.How long has the patient had gerd? 5 years.How long has the patient been taking ppis? 7 months.Demeester score components: day 1 day 2 total: total time ph<4 (enter with 1 place after decimal i.E.5.7%) 6.3 % 12.4 % 9.4 %, upright time ph<4 (enter with 1 place after decimal i.E.5.7%) 6.2 % 19.7 % 14.3 %, supine time ph<4 (enter with 1 place after decimal i.E.5.7%) 4 % 0 % 2.2 %, total number of reflux episodes (enter to nearest whole number) 39 101 139, number of reflux episodes >5 min (enter to nearest whole number) 7 10 17, longest reflux episode (enter to nearest whole number) 14 minutes 23 minutes 23 minutes.Comments: patient has been having pain in abdominal area, a burning sensation, for 5 years.He thought it was related to an abdominal wall hernia and was told that ranitidine might help the symptom.He became aware of severe gerd symptoms about 8 months ago.60 month f/u ¿ (b)(6) 2019.Date test performed: (b)(6) 2019.Date of last ppi dose: (b)(6) 2014.Method used: bravo capsule.Test duration: 48 hours (2 days).Within the last 30 days did the patient take ppi medications? no.Within the last 30 days did the patient take h2 blockers? no.Within the last 30 days did the patient take antacids? no.Demeester score components: day 1 day 2 total: total time ph<4 (enter with 1 place after decimal i.E.5.7%) 3.1 % 6.5 % 4.9 %, upright time ph<4 (enter with 1 place after decimal i.E.5.7%) 5.6 % 10.4 % 8.2 %, supine time ph<4 (enter with 1 place after decimal i.E.5.7%) 0.0 % 0.6 % 0.3 %, total number of reflux episodes 16 51 67, number of reflux episodes >5 min 2 3 5, longest reflux episode (enter to nearest whole number) 13 minutes 9 minutes 13 minutes.Patient seen in clinic for follow-up after testing and treatment (dilation) at outside hospital.All symptoms resolved.Will progress with study schedule.

Event Description

It was reported that post implant (post approval study subject), patient reports sharp pain in the epigastric region.The subject went to the er and was subsequently admitted.Subject reported having an x-ray, ultrasound, egd and later an egd with dilation (completed april 12 at (b)(6) medical center).

Manufacturer Narrative

(b)(4).Corrected date: event month/day/year updated to (b)(6) 2019 based on additional information received.

• Brand Name: LXC13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8607956
• MDR Text Key: 145089930
• Report Number: 3008766073-2019-00343
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2017
• Device Catalogue Number: LXC13
• Device Lot Number: 4516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/04/2019
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 73