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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT
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TORAX MEDICAL INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT Back to Search Results
Model Number LS12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2014
Event Type  Injury  
Event Description
Following a laparoscopic anti-reflux procedure, a pt elected to have their linx device explanted.The pt was diagnosed with multiple sclerosis subsequent to the anti-reflux procedure and will likely need frequent mr diagnostics at exposure levels incompatible with the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred on 09/24/2014 without issue.Uneventful device explant on 10/16/2014.Device found in correct position/geometry at time of explant.Pt in satisfactory condition after explant.
 
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Brand Name
LINX REFLUX MANAGEMENT SYSTEM
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL INC.
shoreview MN
Manufacturer Contact
4188 lexington ave n
shoreview, MN 55126
6513618900
MDR Report Key4257342
MDR Text Key5108862
Report Number3008766073-2014-00033
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/16/2014
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
Device Operator Health Professional
Device Model NumberLS12
Other Device ID Number00855106005011
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/23/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/16/2014
Initial Date FDA Received11/12/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age55 YR
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