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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 Abdominal Pain (1685); Patient Problem/Medical Problem (2688)
Date of Event 12/06/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced pain and mild dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2013 by dr.(b)(6) at (b)(6) hospital.-uneventful device explant due to "severe" retrosternal pain and mild dysphagia on (b)(6) 2016 by dr.(b)(6) at (b)(6) clinic.-device found in correct position/geometry.-a fundoplication was performed immediately after explant.-approximately one and half weeks after explant the patient reported no residual pain, no reflux symptoms, and hasn't taken any ppis.
 
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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 Key6223074
Report Number3008766073-2017-00001
Device Sequence Number828264
Product Code LEI
UDI-Device Identifier00855106005172
UDI-Public00855106005172
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/06/2016
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 Date06/17/2017
Device Model NumberLXC16
Device Lot Number4865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/06/2016
Initial Report FDA Received Date01/04/2017
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 Age46 YR
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