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Catalog Number LXMC16 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Pyrosis/Heartburn (1883); Inflammation (1932)
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Event Date 04/10/2023 |
Event Type
Injury
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Event Description
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It was reported that a linx was explanted due to persistent gerd with demeester score of 74 and evidence of esophagitis on egd, veg 2/8/22: question of possible tiny recurrence; no abnormality of the linx device and normal esophageal motility per radiology read " egd 10/17/22: esophageal furrowing, hill grade ii, bravo 10/17/22: composite score 74, day 1 61, day 2 82.Esophageal bxs: c/w eoe, per op note: the chain was broken and the linx was removed in two pieces.The troublesome symptoms began on (b)(6) 2022.
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Manufacturer Narrative
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(b)(4).Date sent: 9/28/2023.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.No lot number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the linx device is removed, may we ask that the device be returned for analysis? 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).Date sent: 10/23/2023.
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Manufacturer Narrative
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(b)(4).Date sent: 11/28/2023.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.
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Search Alerts/Recalls
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