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Catalog Number LXMC15 |
Device Problems
Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Vomiting (2144)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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Prior to linx placement, the patient did have an egd, ph, and manometry studies done.The linx was implanted on (b)(6) 2023.Nothing unusual noted in removal.It looked actually to be in perfect position, and the hiatus was not too tight.When using the linx sizing device the technique used was ¿pop +3¿ technique to determine the size.The patient did not have an autoimmune disease.That patient was given steroids and reglan.The patient did have a pre-existing conditions of a hiatal hernia.There were not any intra-operative complications during implant.There was a hiatal repair done at the same time as the implant.Upper gi showed hold-up of contrast at the ge junction but no hiatal hernia and linx device appeared to be in good position.Patient had a dilation done and it helped with liquid swallowing for 1 day but then went on to have vomiting for the next 2 days after liquid meals.Patient is unable to advance her diet to solid foods.Patient vomits on liquid diet even after dilation and steroids.
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Manufacturer Narrative
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(b(4).Date sent: 11/13/2023.B3: only event year known: 2023.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.
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Manufacturer Narrative
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(b)(4).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 30163 number, and no non-conformances related to the malfunction were identified.
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Manufacturer Narrative
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(b)(4).Date sent: (b)(6) 2024.
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Manufacturer Narrative
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(b)(4).Date sent: 2/22/2024.Investigation summary overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.
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Search Alerts/Recalls
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