MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS15; ANTI-REFLUX IMPLANT

Model Number	LS-[15]
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device analysis: during the visual analysis, it was determined that the device had three beads with low bead separation force, two of which were depolarized.Based on the follow-up response, there were no records of patient going through an mri prior to explant procedure.However, the review of the manufacturing records indicate that the bead separation force test inspection results of the reported lot number 5279, and serial number (b)(4) were within specifications during production inspection.Therefore, the device investigation suggests that the device was likely damaged during use by being exposed to a static magnetic field (possibly at a different facility).Note that the reported device is mr unsafe per torax ifu.Overall review of the device function and dimensions, excepting the demagnetization/depolarization of several beads, show no anomalies from a device that has been reasonably changed as part of the explant procedure.The dhr for lot# 5279, serial# (b)(4) was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: there is no record, or documentation of the patient having completed a mri prior to the explant.
Event or Problem Description
It was reported that during a procedure the link device was explanted on (b)(6) 2020 so that the patient could get an mri.

• Brand Name: LS15
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10662379
• Report Number: 3008766073-2020-00159
• Device Sequence Number: 19801099
• Product Code: LEI
• UDI-Device Identifier: 00855106005042
• UDI-Public: 00855106005042
• Combination Product (Y/N): N
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2017
• Device Model Number: LS-[15]
• Device Catalogue Number: LS15
• Device Lot Number: 5279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1