MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS13; ANTI-REFLUX IMPLANT

Model Number	LS-[13]
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 2/6/2020.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.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2013.What is the lot number for the ls13? 7221.Was ph testing performed prior to explant to confirm recurrent reflux? device was removed because of neurologic issue necessitates mri.After implant, was the device initially effective in controlling reflux? yes.Device was removed because of neurologic issue necessitates mri.
Event or Problem Description
It was reported that, ¿linx, ls13 device was explanted on (b)(6) 2020 due to patient experiencing a return of gerd symptoms.A nissen fundoplication was performed.
Additional Manufacturer Narrative
(b)(4).Date sent: 06/01/2020.H10: corrected data = h6 (method code updated to include: analysis of production records) & dhr.  corrected dhr = the dhr review for lot 4836 (serial number (b)(6)) was reviewed.No ncs, defects, or reworks related to the product complaint were found.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/29/2020 additional information received: please note that the reported lot number (b)(6) is a serial number.The final pack lot number associated with this serial number is (b)(6).The dhr review for lot 4836 (serial number (b)(6) was reviewed.During the force test inspection, one peak measured below lower specification limit.No other ncs, reworks, or defects were found during the dhr review of this device.

• Brand Name: LS13
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9677787
• Report Number: 3008766073-2020-00021
• Device Sequence Number: 14162428
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• Combination Product (Y/N): N
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2017
• Device Model Number: LS-[13]
• Device Catalogue Number: LS13
• Device Lot Number: 4836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/10/2020; 06/01/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/29/2020; 06/01/2020
• Patient Sequence Number: 1