1.5T LINX, 14B LXMC14

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-10 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..

Event Text Entries

[174858277] (b)(4). Date of event: explant approx. (b)(6) 2019 or (b)(6) 2019. The lot was not provided; therefore, the manufacturing record evaluation could not be performed. Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done (if yes, could you please share the results? ) - yes. On what date did the implant take place? 6 weeks before explant. On what date did the explant take place? 1-2 days before i submitted pc. What is the lot number of the linx device? When using the linx sizing device what technique was used to determine the size? 3 pop. Did the patient have an autoimmune disease? Is the patient currently taking steroids / immunization drugs? Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? How severe was the dysphagia/odynophagia before intervention? Were there any intra-operative complications during implant? No. Was there any hiatal or crural repair done at the same time as the implant? Yes. Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? No. Was the device found in the correct position/geometry at the time of removal? Yes.
Patient Sequence No: 1, Text Type: N, H10


[174858278] It was reported that the linx device was explanted. He said that the patient had the linx device implanted approximately 6 weeks ago. The patient had terrible dysphagia, so it was explanted. He said that the device was scarred in significantly. Explant went fine. No patient consequences. He did not do another reflux procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2020-00008
MDR Report Key9574381
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-10
Date of Report2019-12-16
Date of Event2019-12-15
Date Mfgr Received2020-02-07
Date Added to Maude2020-01-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street4188 LEXINGTON AVENUE NORTH
Manufacturer CitySHOREVIEW MN
Manufacturer Phone6107428552
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.5T LINX, 14B
Generic NameANTI-REFLUX IMPLANT
Product CodeLEI
Date Received2020-01-10
Returned To Mfg2020-01-08
Model NumberLXMC14
Catalog NumberLXMC14
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTORAX MEDICAL, INC.
Manufacturer Address4188 LEXINGTON AVENUE NORTH SHOREVIEW MN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-10

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