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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/13/2018
Event Type  Injury  
Event Description
Following a laparoscopic anti-reflux procedure, a patient had the linx device explanted due to unknown reasons.Additional information is being sought from the surgeon.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred on an unknown date.Device explant due to unknown reasons occurred on (b)(6) 2018.
 
Event Description
Following a laparoscopic anti-reflux procedure, a patient had the linx device explanted due to unknown reasons.Additional information is being sought from the surgeon.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred on an unknown date.Device explant due to unknown reasons occurred on (b)(6) 2018.
 
Manufacturer Narrative
Patient code 3190, method code 10, results code 213, and conclusion codes 22 and 67.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINX REFLUX MANAGEMENT SYSTEM
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue n
shoreview MN 55126
MDR Report Key7868916
MDR Text Key119975095
Report Number3008766073-2018-00146
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
PMA/PMN Number
P100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2018
Date Manufacturer Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age50 YR
-
-