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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL INC. LINX REFLUX MGMT SYS
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TORAX MEDICAL INC. LINX REFLUX MGMT SYS Back to Search Results
Model Number LX14
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Other  
Event Description
Following a laparoscopic anti-reflux procedure that included the linx device, a pt experienced long-term recurrence of gerd symptoms leading to explant of the linx device.Anti-reflux procedure and linx device implantation occurred on (b)(6) 2011.Recurrence of gerd symptoms first reported at one year follow-up.Uneventful device explanted on (b)(6) 2013 with device found in correct position and geometry.Pt underwent toupet fundoplication after linx device explant.Endoscopy (b)(6) 2014 indicates no visible esophagitis, no heartburn symptoms, and intermittent dysphagia.
 
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Brand Name
LINX REFLUX MGMT SYS
Manufacturer (Section D)
TORAX MEDICAL INC.
shoreview MN
Manufacturer Contact
4188 lexington ave n
shoreview, MN 55126-0000
6513618907
MDR Report Key3698726
MDR Text Key20973216
Report Number3008766073-2014-00004
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
10049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/24/2014
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 Expiration Date02/26/2014
Device Model NumberLX14
Device Lot Number2233
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2014
Initial Date FDA Received03/19/2014
Date Device Manufactured02/01/2010
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; Disability;
Patient Age142 YR
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