MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 14 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM14

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/16/2024.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a linx implant was surgically removed.Initially implanted (b)(6) 2019.Patient female, 62 years old.Unknown reason.

Manufacturer Narrative

(b)(4).Date sent: 4/24/2024.Additional information was requested, and the following was obtained: 1.What was the reason for the explantation? dysphagia due to cardiastenosis with linx band in place condition after diagnostic laparoscopy, laparoscopic anterior hiatoplasty, placement of an anti-reflux magnetic band (linx), esophagogastroduodenoscopy on (b)(6) 2019 for macroreflux, gastroesophageal reflux disease with grade ii reflux esophagitis and axial hiatal sliding hernia condition after right breast carcinoma with surgery, chemotherapy and radiotherapy hemorroids ii.Degree significant slightly narrowed sigmoid elongatum.Diverticulosis without lumen narrowing in the sigmoid colon arterial hypertension hypothyroidism with l-thyroxine substitution fibromyalgia condition after left knee surgery, condition after left elbow surgery, condition after caesarean section, condition after two shoulder operations for left fracture, condition after breast reduction on both sides, allergy: penicillin.2.Has the patient had an mri? no.3.Could the implant be explanted without complications? if not, what complications occurred? did the patient come to any harm? yes.4.What alternative treatment was provided to the patient? balloon dilatation every 3 months did not help, then explantation we performed an intraoperative hemifundoplication (120 degrees) and dorsal hiatoplasty.5.Can the implant be sent in for examination? (this requires a declaration of consent from the patient) no, has been discarded.6.Do you have any further information that could be helpful for the examination? no.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2024.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 is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device 24508 number, and no non-conformances related to the malfunction were identified.

• Brand Name: LINX 1.5T 14 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18726204
• MDR Text Key: 335712568
• Report Number: 3008766073-2024-00036
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: LXM14
• Device Lot Number: 24508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/23/2024
• Supplement Dates FDA Received: 04/11/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female