MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 16 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM16

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Urinary Retention (2119)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 1/9/2023.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.Additional information received: patient identifier: (b)(6), (b)(6) hospital, (b)(6), sex: male, age (at time of consent): 58 years.Start date: 15 sep 2022, alert date: 08- dec- 2022, country of event: ous, model: lxm16, device lot number: 26799, date of surgery: (b)(6) 2022 , adverse event term: painful urinary retention post surgery, site awareness date: (b)(6) 2022 , end date: (b)(6) 2022 , severity: mild, is the adverse event serious? yes, no required in-patient hospitalization or prolongation of existing hospitalization: yes, admission date: (b)(6) 2022 discharge date: (b)(6) 2022 , none: yes, relationship to primary study procedure: not related, outcome: recovered/resolved, discharge date : (b)(6) 2022 - (b)(6) 2022.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : blank yes.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : yes => no relationship to study procedure : not related, possible.Hospital stay was from sept (b)(6) 2022.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 via clinical trial patient (b)(4) experience, painful urinary retention post surgery.Relationship to study device: not related.

Manufacturer Narrative

(b)(4).Date sent: 1/9/2023 b2: is hospitalization initial/prolonged - yes.E4: reporter also sent report to fda - no.

Manufacturer Narrative

(b)(4).Date sent: 1/20/2023.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 batch number 26799 , and no related non-conformances were identified.

Manufacturer Narrative

(b)(4); date sent: 2/7/2023.Additional information received: required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: (b)(6) 2022; discharge date: (b)(6) 2022.Relationship to primary study procedure: possible.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : no /yes.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : yes /n/a.

• Brand Name: LINX 1.5T 16 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16120683
• MDR Text Key: 308711015
• Report Number: 3008766073-2023-00003
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Catalogue Number: LXM16
• Device Lot Number: 26799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 12/20/2022; 01/20/2023; 01/24/2023
• Supplement Dates FDA Received: 01/09/2023; 01/20/2023; 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male