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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT
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LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT Back to Search Results
Catalog Number LXMC16
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Pyrosis/Heartburn (1883); Hernia (2240); Insufficient Information (4580)
Event Date 05/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Only the event year is known 2018.Unknown; captured as awareness date.No lot number was provided therefore a device history could not be done.Additional information received: spoke with patient who indicated his surgeon is (b)(6), md.The explant procedure had not been scheduled at the time i spoke with him.He gave permission for us to speak to dr.(b)(6) office to gather needed information.Will follow up with (b)(6) in dr.(b)(6) office to determine if explant has been scheduled and update file.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 date of implant? what is the product code? what is the device lot number? what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis?.
 
Event Description
It was reported that the patient had a linx implant which has separated.It was implanted in 2018, no model number was given.
 
Manufacturer Narrative
(b)(4).Date sent: 6/23/2021.Additional information was requested, and the following was obtained: what was the exact date of implant? what is the product code? what is the device lot number? what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? answer: i do not know any of the answers to those questions.Additional information received: the patient indicated his explant procedure has been scheduled for (b)(6) 2021.
 
Manufacturer Narrative
(b)(4).Date sent: 6/28/2021.Additional information was requested, and the following was obtained: this possibly discontinuous device was removed (b)(6) 2021 at (b)(6) medical center, (b)(6).Dr.Removed a lxmc16, replace with a lxmc17.
 
Manufacturer Narrative
(b)(4).Date sent: 7/2/2021.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
 
Manufacturer Narrative
(b)(4), date sent: 8/25/2022.The linx device from (b)(4) was scanned using the nsi x3000 micro-focus x-ray / computed tomography (ct) scanner at ethicon (cincinnati, oh) on (b)(6) 2022.The device was received in a discontinuous configuration and both ends of the discontinuous device were ct scanned.Visualization & measurement of key internal features were made using this technology, primarily the washer through hole diameter in the bottom link and the weld ball diameter in the top link.Washer through hole: the diameter of the washer through hole of the discontinuous bottom link was approximately 0.024¿ at the narrowest point.This is outside the torax specification.The hole appeared to be slightly elongated at the entry and exit point of the washer link weld ball: a cross section of the link wire weld ball that remained outside of the discontinuous top link is shown.The diameter was measured to be approximately 0.024¿.This measurement is within the torax specification.The lot number of the device was not reported.However, the reporting facility had a 16-bead linx device that was outside of 2018 linx recall product bounding at the time of implant; hence, to be conservative, this device was considered to be outside of recall.
 
Manufacturer Narrative
(b)(4).Date sent: 10/13/2022.Operation notes attached.
 
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Brand Name
LINX 1.5 16 BEAD US
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer Contact
kara ditty-bovard
4188 lexington avenue north
shoreview, MN 55126
6107428552
MDR Report Key11912630
MDR Text Key253499571
Report Number3008766073-2021-00099
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
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,Followup,Followup,Followup,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLXMC16
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received10/03/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient SexMale
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