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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT
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TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT Back to Search Results
Catalog Number LXMC15
Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524)
Patient Problems Pyrosis/Heartburn (1883); Insufficient Information (4580)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Only event year known: 2020 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.No lot number was provided therefore a device history could not be done.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 date of implant? 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.What is the product code for this complaint? what is the device lot number? 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? when is the device removal date 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 there was a discontinuous linx device.No other information is available.
 
Manufacturer Narrative
(b)(4) date sent: 03/08/2021.
 
Manufacturer Narrative
(b)(4).Date sent: 1/25/2021.Photo was provided for review by ethicon medical safety officer.Following are their observations: "i reviewed a picture of a screen showing a spot film image from an ugi exam on (b)(6) 2020.The xray image showed a discontinuous linx device.The annular shape was absent, and the appearance was c-shape consistent with a discontinuous device." however, a hands on analysis of the affected device is needed to establish the mechanism/cause of failure.Additional information was requested, and the following was obtained: what was the date of implant? (b)(6) 2019.What symptoms lead to the discovery of the discontinuous device? when did they begin? the patient was doing fine then had an unexplained recurrence of symptoms (gerds).What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.(b)(6) 2020.What is the product code for this complaint? lxmc15.What is the device lot number? unknown.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? unknown.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? unknown.Did the patient have any other surgeries in the area? no.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.No post-implant images prior to attached image of the discontinuous device.What is the management plan? is device removal scheduled? when is the device removal date scheduled? is a replacement linx or fundoplication planned? removal took place on (b)(6) 20.Patient converted to toupe fundoplication.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? dr.Did record a procedure video.Trying to obtain video.When and if the linx device is removed, may we ask that the device be returned for analysis? the device had to be sent to pathology and is currently pending release.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: do we know the lot number of this device? do you know if we can obtain a video of the explant?.
 
Manufacturer Narrative
(b)(4).Date sent: 04/06/2021.Additional information received: the patient was implanted on (b)(6) 2017 and the explant procedure occurred on (b)(6) 2020.Device analysis: the visual analysis found that the returned device had an exposed well ball paired with the washer side of the adjacent bead.The affected washer through-hole diameter was measured with computed tomography (ct) and found to be greater than specification.The through-hole overall appears to be round and concentric.The exposed weld ball diameter of the exposed weld ball was measured.The diameter is within the specifications.These measurements were confirmed during the ct analysis.A small interference was found between the diameters of the out-of-specification washer through-hole and the corresponding exposed weld ball.It is presumed that a certain geometric combination of the weld ball and the washer through-hole resulted in the device separation in vivo.The link length and tensile force were found to meet the applicable specifications.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure.The implanting facility purchased 15-bead linx device that was outside of 2018 linx recall prior to the implant date on (b)(6) 2017.Hence, to be conservative, this device is assumed to be outside of 2018 linx recall.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Corrected data: (b)(4).
 
Manufacturer Narrative
(b)(4), date sent: 4/6/2021, corrected data: h6; this information was omitted on the previous report (mwr-08032021-0000910372).
 
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Brand Name
1.5T LINX, 15B
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue north
shoreview MN
MDR Report Key11096734
MDR Text Key225724760
Report Number3008766073-2020-00206
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLXMC15
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/17/2021
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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