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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 LXC14
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/23/2015
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure and device implant on (b)(6) 2015.-uneventful device explant (b)(6) 2015.-linx device found in the correct position/geometry.-after device removal, patient underwent nissen fundoplication.
 
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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 Key5384367
Report Number3008766073-2016-00008
Device Sequence Number245741
Product Code LEI
UDI-Device Identifier00855106005158
UDI-Public00855106005158
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 Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Report Date (Section B) 12/23/2015
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 Date09/25/2017
Device Model NumberLXC14
Device Lot Number5288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2016
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/21/2016
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; Other;
Patient Age30 YR
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