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

Model Number LS-[15]

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2020

Event Type  malfunction  

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 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
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10662379
• MDR Text Key: 210870268
• Report Number: 3008766073-2020-00159
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005042
• UDI-Public: 00855106005042
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1