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

Catalog Number	LS14
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, assumed 1st day of month that complaint was reported.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: 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 the implant? no.Was mesh used at time of implant? no.What was the reason for removal of the linx device? ongoing gerd symptoms was the device found in the correct position/geometry at the time of removal? yes.Fundoplication was performed at the time of explant.Was a replacement linx device used? no.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.Was there an alleged deficiency with the linx device? did the patient have an autoimmune disease? is the patient currently taking steroids / immunation drugs?.
Event or Problem Description
It was reported that during an unknown procedure, there was an explant and conversion to fundoplication that happened last week.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found.

• Brand Name: LS14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 7966851
• Report Number: 3008766073-2018-00181
• Device Sequence Number: 16502243
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 02/19/2019
• Device Catalogue Number: LS14
• Device Lot Number: 7640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/07/2018
• Patient Sequence Number: 1
• Patient Age: 76 YR