|
Catalog Number LXMC15 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pyrosis/Heartburn (1883)
|
Event Date 01/01/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4); date sent; 2/13/2024.B3: only event year known: 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.Additional information was requested, and the following was obtained: lot 28780.After implant, was the device initially effective in controlling reflux? yes.Implant took place (b)(6) 2022.When did the recurrent reflux begin? patient reported recurrent symptoms during visit on (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 that the patient has recurrent reflux.Postsurgical changes without residual or recurrent hernia ph bravo- patient spent 10.7% of time in reflux with 110 acid reflux episodes and composite demeester score 32.7.Testing did not reveal discontinued linx device.The patient did not undergo any mri.
|
|
Manufacturer Narrative
|
(b)(4), date sent: 2/22/2024.
|
|
Manufacturer Narrative
|
(b)(4).Date sent: 3/15/2024.Investigation summary: a washer was noted, to be disconnected from a clasp bead.The washer was observed, to be bent outwards and weld tracks are visible on both the washer and clasp bead.These findings suggest, that the washer was pulled out of the clasp bead, due to external forces applied, during an explant procedure.The remaining device characteristics, excepting the issues called out above, show no anomalies for a device that has been reasonably changed.As part of the explant procedure and tooling marks were noted, in some beads and washer.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed, for the finished device 28780 number.And no non-conformances related to the malfunction were identified.
|
|
Search Alerts/Recalls
|
|
|