Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT Back to Search Results
Model Number LXC15
Medical Device Problem Codes Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Heartburn/Indigestion (1883)
Date of Event 08/13/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd symptoms leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred on (b)(6) 2014 without issue.-the patient reported ongoing gerd symptoms and the device was explanted without issue and a fundoplication was performed on (b)(6) 2018.-the linx device was in the correct position and geometry.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINX REFLUX MANAGEMENT SYSTEM
Common Device Name
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue n
shoreview MN 55126
MDR Report Key7854778
Report Number3008766073-2018-00145
Device Sequence Number1986833
Product Code LEI
UDI-Device Identifier00855106005165
UDI-Public00855106005165
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/13/2018
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 No Information
Device Expiration Date01/04/2017
Device Model NumberLXC15
Device Lot Number4279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date09/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
Patient Age66 YR
-
-