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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 LS16
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Heartburn/Indigestion (1883)
Date of Event 04/01/2016
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) 2013.Uneventful device explant (b)(6) 2016.Linx device found in the correct position/geometry.Hiatal hernia (4-5cm) developed between the time of implant and explant.Patient reported severe coughing fit in (b)(6) 2015 that correlated to the return of reflux symptoms.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 Key5645237
Report Number3008766073-2016-00034
Device Sequence Number172435
Product Code LEI
UDI-Device Identifier00855106005059
UDI-Public00855106005059
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) 04/11/2016
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 Date10/15/2016
Device Model NumberLS16
Device Lot Number4052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2016
Initial Report FDA Received Date05/10/2016
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 Age75 YR
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