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	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a linx removal and replacement procedure, the patient had returned to have the suture type, 14 bead linx device removed because the patient had an mri procedure and the linx device became demagnetized.There were no patient consequences reported.

• Brand Name: LS14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8587789
• Report Number: 3008766073-2019-00334
• Device Sequence Number: 1836043
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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 Catalogue Number: LS14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1