MAUDE Adverse Event Report: TORAX MEDICAL LINX MAGNETIC SPHINCTER

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/28/2016

Event Type  malfunction  

Event Description

Linx magnetic sphincter implant problem.High resolution motility study results: on 5 out of 10 wet swallows, the pt (me) had no peristalsis, on the other 5 he had normal peristaltic waveform with slightly low pressures in 30 to 35 mmhg.Doctor's impression: peristalsis on 50% of swallows with low amplitude.Otherwise primary nonconduction of swallows.The pt has a non-specific motility disorder.Linx will prevent reflux in many, but it can have a huge effect on people's motility in order to do that - like me.Dr.(b)(6), my surgeon is interested in new, important products like this and is to be commended for his efforts, but the product has issues.We pts should be made fully aware of possible motility problems which could be serious and require explant years after implant.Torax medical does not have any info, testing done, or long term motility testing info available to pts (or doctors?) for conditions like mine, peristalsis, 50% motility swallow with low amplitude.A serious complication that could necessitate removal.I want to know what motility scores are for all linx pts especially long term pts 2-3 years out or more.Serious lack of motility manometry bravo ph testing and subsequent complications over time.

• Brand Name: LINX MAGNETIC SPHINCTER
• Type of Device: LINX MAGNETIC SPHINCTER
• Manufacturer (Section D): TORAX MEDICAL
• MDR Report Key: 5843014
• MDR Text Key: 51131793
• Report Number: MW5063803
• Device Sequence Number: 1
• Product Code: LEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR