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 LXC14
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Dysphagia/ Odynophagia (1815)
Date of Event 02/23/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced mild dysphagia and throat pain resulting in explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implant on (b)(6) 2013 by dr.(b)(6) at (b)(6) hospital.Uneventful device explant on (b)(6) 2017 by dr.(b)(6) at (b)(6) hospital.Device found in the correct position/geometry at the time of removal.Patient is reported as doing well and swallowing better after removal.
 
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 north
shoreview MN 55126
MDR Report Key6425554
Report Number3008766073-2017-00039
Device Sequence Number551108
Product Code LEI
UDI-Device Identifier00855106005158
UDI-Public00855106005158
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/23/2017
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 Physician
Device Model NumberLXC14
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/23/2017
Initial Report FDA Received Date03/22/2017
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; Disability;
Patient Age55 YR
-
-