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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT
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TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT Back to Search Results
Model Number LXMC16
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).As the device was not returned, an analysis investigation could not be performed.  a conclusion could not be reached as to what may have caused or contributed to the event.  the lot was not provided; therefore, the manufacturing records evaluation could not be performed.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 exact implant date? what is the lot number for the linx device? 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? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
 
Event Description
It was reported that the linx was removed due to recurrent reflux symptoms.Linx was implanted (b)(6) 2019.
 
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Brand Name
LINX 1.5 16 BEAD US
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue north
shoreview MN
Manufacturer Contact
kara ditty-bovard
4188 lexington avenue north
shoreview, MN 
6107428552
MDR Report Key10843230
MDR Text Key216343737
Report Number3008766073-2020-00181
Device Sequence Number1
Product Code LEI
UDI-Device Identifier00855106005363
UDI-Public00855106005363
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLXMC16
Device Catalogue NumberLXMC16
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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