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 LS13
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Dysphagia/ Odynophagia (1815)
Date of Event 07/01/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hiatal hernia repair and linx device implantation occurred without issue (b)(6) 2012.Dilations performed in (b)(6) 2012, (b)(6) 2016 prior to explant.Device explant occurred without issue on (b)(6) 2016.Linx device found in the correct position/geometry.Patient's dysphagia symptoms have improved after explant.
 
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 Key5839731
Report Number3008766073-2016-00052
Device Sequence Number1164436
Product Code LEI
UDI-Device Identifier00855106005028
UDI-Public00855106005028
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 Year2012
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/08/2016
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 Date04/17/2016
Device Model NumberLS13
Device Lot Number3499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2016
Initial Report FDA Received Date08/02/2016
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 Age53 YR
Patient Weight92
-
-