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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: magnetic sphincter augmentation device removal: surgical technique and results at medium-term follow-up.Author/s: davide bona, greta saino, emanuele mini, francesca lombardo, valerio.Panizzo, marta cavalli, gianluca bonitt, giampiero campanelli2, alberto aiolfi.Citation: langenbeck's archives of surgery (2021) 406:2545¿2551 https://doi.Org/10.1007/s00423-021-02294-71.The purpose of this (b)(6) study was to analyze our experience with msa removal and describe the surgical technique, intraoperative technical aspects, and medium-term follow-up results.During the study period, 32 msa devices were implanted at our institution and five patients underwent msa explant.Four patients were males and the median age was 47 years (range 44¿55).The median body mass index (bmi) was 23.1 kg/m2 (range 20.9¿24.3).The median implant duration was 46 months (range 31¿72).All patients underwent a single-stage laparoscopic removal with intraoperative endoscopic assistance.The most common anti-reflux procedure performed in conjunction with msa device removal was an anterior dor fundoplication (df) (n = 2) followed by toupet fundoplication (tf) and crural repair (n = 2).In the patient that experienced msa erosion, an anterior partial fundoplication was performed (n = 1) after removal.A (b)(6) year-old male patient experienced recurrent heartburn and chest pain.A (b)(6) year-old female patient experienced dysphagia, chest pain and erosion.A (b)(6) year-old male patient experienced dysphagia.A (b)(6) year-old male patient experienced recurrent heartburn, epigastric pain and regurgitation.A (b)(6) year-old male patient experienced recurrent heartburn and regurgitation.The median postoperative follow-up was 41 months (range 12¿51).At the last follow-up, the median gerdhrql was significantly improved compared to preoperative data (6 ± 1.8 vs.24 ± 9.3; p < 0.05), 80% of patients were off ppi, and patients¿ quality of life assessed with the sf-36 questionnaire was improved.In conclusion, the msa device can be safely explanted through a single-stage laparoscopic procedure.Tailoring a fundoplication, according to preoperative patient symptoms and intraoperative findings, seems feasible and safe with a promising trend toward improved symptoms and quality.

• 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: 13313935
• MDR Text Key: 289182929
• Report Number: 3008766073-2022-00014
• 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: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• 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
• Date Manufacturer Received: 01/05/2022
• 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