UNK LINX MAGNETIC IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..

Event Text Entries

[182230598] (b)(4). Date sent: 03/04/2020. Only event year known: 2020. The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed. Additional information was requested, and the following was obtained: what was the implant date? What was the explant date? What is the lot number for the linx device? What is the product code for the linx device that was removed? Was ph testing performed prior to explant to confirm recurrent reflux? After implant, was the device initially effective in controlling reflux? When did the recurrent reflux begin? Response: no further information available.
Patient Sequence No: 1, Text Type: N, H10


[182230599] It was reported that export/explantation of linx after sleeve and reflux symptoms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2020-00037
MDR Report Key9788995
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-02-10
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-04
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 NameUNK LINX MAGNETIC IMPLANT
Generic NameANTI-REFLUX IMPLANT
Product CodeLEI
Date Received2020-03-04
Catalog NumberUNK LINX MAGNETIC IMPLANT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORAX MEDICAL, INC.
Manufacturer Address4188 LEXINGTON AVENUE NORTH SHOREVIEW MN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-04

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