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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 LXC16
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 06/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced severe dysphagia leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure with linx device implant on (b)(6)2015 by dr.(b)(6).-prior to removal, the patient was experiencing some esophageal dysmotility, distal esophageal diverticulum, severe regurgitation, and nausea.-device explant (b)(6)2017 by dr.(b)(6) due to severe dysphagia; patient also experiencing ongoing gerd symptoms, esophageal spasms, dehydration, and po intolerance.-device was found in the correct/position geometry at the time of removal; it was noted there was "significantly dilated proximal esophagus".-patient reported as doing okay after explant.
 
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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 Key6726295
Report Number3008766073-2017-00079
Device Sequence Number11008742
Product Code LEI
UDI-Device Identifier00855106005172
UDI-Public00855106005172
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2017
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 Date10/08/2018
Device Model NumberLXC16
Device Lot Number6865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2017
Initial Report FDA Received Date07/19/2017
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 Age54 YR
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