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 LS15
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event 12/14/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and moderate dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred without issue on (b)(6) 2014 by dr.(b)(6).Device explant due to ongoing gerd and moderate dysphagia occurred without issue on (b)(6) 2017 by dr.(b)(6); a fundoplication was performed at the time of explant.Device was found in the correct position/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 Key7182921
Report Number3008766073-2018-00004
Device Sequence Number16184003
Product Code LEI
UDI-Device Identifier00855106005042
UDI-Public00855106005042
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/14/2017
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 Expiration Date11/20/2017
Device Model NumberLS15
Device Lot Number5550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2017
Initial Report FDA Received Date01/11/2018
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; Disability;
Patient Age56 YR
Patient Weight100
-
-