1.5T LINX, 15B LXMC15

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 2020-02-24 for 1.5T LINX, 15B LXMC15 manufactured by Torax Medical, Inc..

Event Text Entries

[180552956] (b)(4). Date sent: 02/24/2020 attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What was the reason for removal of the linx device? On what date did the implant take place? Does the patient have any of the allergies to metals? If so, what test have been done to test for metal allergies. Is the patient currently taking currently taking steroids / immunization drugs? Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? Was there any hiatal or crural repair done at the same time as the implant? Was mesh used at time of implant? At the time of removal, was the device found in the correct position/geometry at the time of removal? Have the symptoms resolved since the device was explanted?
Patient Sequence No: 1, Text Type: N, H10


[180552957] It was reported that the linx was explanted. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2020-00034
MDR Report Key9744734
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-24
Date of Report2020-02-04
Date of Event2020-02-03
Date Mfgr Received2020-03-25
Device Manufacturer Date2019-02-04
Date Added to Maude2020-02-24
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, 15B
Generic NameANTI-REFLUX IMPLANT
Product CodeLEI
Date Received2020-02-24
Model NumberLXMC15
Catalog NumberLXMC15
Lot Number24451
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORAX MEDICAL, INC.
Manufacturer Address4188 LEXINGTON AVENUE NORTH SHOREVIEW MN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-24

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