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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX; IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
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TORAX MEDICAL, INC. LINX; IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Erosion (1750); Complaint, Ill-Defined (2331)
Event Date 03/08/2017
Event Type  malfunction  
Event Description
Patient had a linx device- magnetic beads that support closure of the esophageal sphincter as treatment for gastroesophageal reflux disease (gerd) placed about 4.5 years ago.He recently had renewed symptoms of gerd and had an upper gi series done almost 3 months ago, which showed narrowing at the gi junction at the level of the linx device.It was subsequently determined that the linx device had eroded into the distal esophagus and 4 of the 12 beads were inside the lumen of the esophagus.The wire that holds the beads was cut and the whole chain was removed by an endoscope.Manufacturer response for reflux management system, linx (per site reporter): they want to have the device to analyze.It was not implanted at this facility.
 
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Brand Name
LINX
Type of Device
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue north
shoreview MN 55126
MDR Report Key6529633
MDR Text Key73940972
Report Number6529633
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/11/2017
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer04/11/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO.
Patient Outcome(s) Other;
Patient Age44 YR
Patient Weight73
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