MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS16; ANTI-REFLUX IMPLANT

Catalog Number	LS16
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported that the patient had a ls16 linx device implanted six years ago, due to reflux.The patient also had a hiatal hernia, during the implant, that was not repaired with the implant of the linx.On (b)(6) 2019, the patient's hiatal hernia herniated, and a hiatal hernia repair was performed and the ls16 linx device was explanted and an lxmc17 linx device was replaced.There were no abnormal observations.The same doctor performed both procedures.
Additional Manufacturer Narrative
(b)(4).Date sent: 06/14/2019.The dhr for lot 5491 was reviewed.No ncs, defects, or reworks were found.Additional information requested and received: patient bmi or weight: 26.23.Implant date: (b)(6) 2014.Date of explant:(b)(6) 2019.Device size: 16 bead - clasp.Lot: 5491.Serial: (b)(4).Pre-implant test: barium swallow, ph, egd.Results: egd ((b)(6) 2014): 4cm sliding hiatal hernia, hill grade iv valve, mild esophagitis.Bravo: demeester score (05/2014): 60.4.Barium swallow ((b)(6) 2014): normal esophagram.Additional diagnostics: video esophagram/cxr: (b)(6) 2019.Egd/bravo: 3/21/19- la grade c esophagitis, 2 cm hiatal hernia.Bravo: (b)(6) 2018: demeester 42.5 and 30.9.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? ongoing gerd symptoms and recurrent hiatal hernia.Was the device found in the correct position/geometry at the time or removal? yes.Was a replacement linx device used? yes.Device size: 17 bead.Lot # 24371.The device is not available for return as it is retained by the patient.The patient does not plan to return the device to the company.I can confirm that lxmc17 was the replacement device with lot number 24371.

• Brand Name: LS16
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8655407
• Report Number: 3008766073-2019-00354
• Device Sequence Number: 2663170
• Product Code: LEI
• UDI-Device Identifier: 00855106005059
• UDI-Public: 00855106005059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2017
• Device Catalogue Number: LS16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Patient Age: 77 YR