MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144); Burning Sensation (2146); Choking (2464); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown, assumed 1st day of month that event took place.Implant date: exact implant date is unknown.The only known fact is year of 2016.Assumed first day of month and first month of the year.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 exact implant date? what is the product code? what is the lot number? when the device is explanted can you please email productcomplaint1@its.Jnj.Com and reference (b)(4) and let us know the date of the explant? did the surgeon (that never done a linx before) do an x-ray before the did the dilation (stretching)? if yes, can you please share a copy of the x-ray? would you please share the name and contact information from the surgeon that did the dilation? we will reach out to that surgeon for additional information.When we do, they will ask for your wife¿s name and date of birth, can you please provide that information for us?.

Event Description

It was reported that the patient had a linx implanted in 2016 and had great results.Was in the hospital for esophageal spasm after food poisoning in october and was vomiting and then had chest pain/ burning and a choking feeling.She was admitted to the hospital and checked her heart and found nothing.Then, she went to new surgeon (that has never done a linx), did a scope and "stretched the linx" on (b)(6) 2021 and since then has had reflux again.Patient requests new linx surgeon.Email sent with linx surgeon link and provided several surgeons for her to review.Referred patient to her physician to evaluate status of linx device.

Manufacturer Narrative

(b)(4).Date sent: 3/31/2022.Additional information was requested, and the following was obtained: what was the exact implant date? what is the product code? what is the lot number? when the device is explanted can you please email (b)(4) and reference (b)(4) and let us know the date of the explant? did the surgeon (that never done a linx before) do an x-ray before the did the dilation (stretching)? if yes, can you please share a copy of the x-ray? would you please share the name and contact information from the surgeon that did the dilation? we will reach out to that surgeon for additional information.When we do, they will ask for your wife¿s name and date of birth, can you please provide that information for us? answer = the implant date was (b)(6) 2017.It is unknown to the patient if an xray was done at the time of the endoscope and stretching.A flouroscope (swallow test) was done on (b)(6) 2021 in preparation for the endosope done on (b)(6) 2021.The patient's gp has requested all medical records from albany surgical concerning the initial dr.Visits linx implant, and subsequent visits including the endoscope and stretching of the linx, and follow-up dr.Visits.The patient has a written report of the flouroscope report.Acid reflux has returned after the stretching.No acid reflux medication was necessary after the linx implant until the stretching was done since then 2 pepcid 20mg tablets are required each day to control reflux.We anticipate the product code and lot number will be available in those records.The physician the did the implant was dr.(b)(6), (deceased) (b)(6).The surgeon that did the dilation was (b)(6) md, (b)(6).The patient's name: (b)(6).Dob: (b)(6) 1946.Last four of ssn: (b)(6).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: it was stated in the email ¿2 pepcid 20mg tablets are required each day to control reflux.¿ was the pepcid over the counter or was it doctor prescribed medication? it was also stated in the email ¿the surgeon that did the dilation was (b)(6) md, (b)(6)¿.Do you have a contact email or phone number for this surgeon? what state is albany in? d6a.

Manufacturer Narrative

(b)(4); date sent: 4/20/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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 is the product code of the linx device that the patient had implanted on (b)(6) 2017? what is the lot number? when the device is explanted can you please email productcomplaint1@its.Jnj.Com and reference (b)(4) and let us know the date of the explant? is there an x-ray that was taken before the dilation? if yes, can you please share a copy of the x-ray? could you please provide the medical records of the endoscope and the dilation? could you please provide the report for the fluoroscope that was done on (b)(6) 2021? the patient told us that she is taking pepcid 20mg daily.Is the pepcid over the counter or doctor prescribed? what is the management plan for this patient?.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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 55126 ; 6107428552
• MDR Report Key: 13790490
• MDR Text Key: 287539987
• Report Number: 3008766073-2022-00052
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR