MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS14; ANTI-REFLUX IMPLANT

Model Number	LS-[14]
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); No Code Available (3191)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Unknown, assumed the 1st day of month the complaint was reported.The dhr for lot 1819 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was received: besides gerd¿s were there any other symptoms leading to the discovery of the discontinuous device? when did they begin (including gerd¿s)? patient is recently undergoing chemotherapy for multiple myeloma which has made her ill.She noted a return of gerd symptoms after a bout of retching, returned to the office on (b)(6) 2020 was the device initially effective in controlling reflux? yes, the patient had been doing well.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? chemo did the patient undergo an mri since device implant? no, this device is not mri compatible.Did the patient have any other surgeries in the area? no does the device appear to be in a continuous annular state in these images? no, on the barium swallow, the device appears to be discontinuous.What is the management plan? the surgeon was going to discuss the options with the patient.Not aware of a definitive plan when i last spoke with the surgeon.Is device removal scheduled? no, not yet.Is a replacement linx or fundoplication planned? unsure ethicon medical review: i reviewed some endoscopy images which showed a small hill type ii gej on retroflexion with a normal looking antrum, pylorus and duodenum.There were also 3 fluoroscopic images of the gej taken during the endoscopy procedure which showed a c-shaped linx device at the gej with a distended stomach.A bravo capsule was present in the first image and the endoscope in the esophagus in the other two images.The fluoroscopic images were consistent with a discontinuous linx device given the c-shape and wide gap between beads.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that the patient had a return of gerd after having the linx device implanted on (b)(6) 2009.An xray was taken and it was discovered that the linx device was discontinuous and in a c shape.It has not been determined if the patient will have the device removed due to the patient being diagnosed with cancer.
Additional Manufacturer Narrative
(b)(4).Date sent: 07/31/2020.
Additional Manufacturer Narrative
(b)(4).Date sent: 08/12/2020.Additional information was received: she has not made a decision.She knows of your offer to give her a new device.She has some other significant health issues now and is uncertain about going through another procedure.

• Brand Name: LS14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10258327
• Report Number: 3008766073-2020-00095
• Device Sequence Number: 3458506
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2013
• Device Model Number: LS-[14]
• Device Catalogue Number: LS14
• Device Lot Number: 1819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/06/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/12/2020
• Patient Sequence Number: 1