MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS15; ANTI-REFLUX IMPLANT

Model Number LS-[15]

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown; captured as awareness date.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.Additional information was requested, and the following was obtained: do we have permission to reach out to your explant surgeon to ask further questions? if yes, what is the name and contact information for your surgeon? please follow call our customer service number at 1-877-384-4266 and reference pc#001287021 to have your questions answered about melted band.The below questions will be sent to your surgeon upon permission from you.Please describe what the linx looked like upon explant? do you have photos of the device after explant? if yes, please send a photo to productcomplaint1@its.Jnj.Com after electrocution did the patient gerds symptoms return? at the time of removal were there any indications around the linx device that had tissue injury? answer: you can talk to anyone you like i'm going to give these emails to my attorney, she will probably more helpful to you in getting the info you need.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 due to being electrocuted the patient had the ls15 explanted and it looked like the elastic band had melted.Patient had to go back on medication, protonic.

Manufacturer Narrative

(b)(4).Date sent: 3/15/2023 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 3765 , and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 10/2/2023.Additional information received: there is no possibility that the linx device can be the cause of an electric shock.In the reported complaint, the patient was electrocuted and the linx device appears to have been damaged by the electrical current.The linx was affected by the electrical shock, but was not the cause.6.Health effect - clinical code.E2104.

• Brand Name: LS15
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16378446
• MDR Text Key: 309563789
• Report Number: 3008766073-2023-00023
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005042
• UDI-Public: 00855106005042
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2016
• Device Model Number: LS-[15]
• Device Catalogue Number: LS15
• Device Lot Number: 3765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 10/02/2023
• Supplement Dates FDA Received: 03/15/2023; 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention