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Model Number 8637-40 |
Device Problems
Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); Irritability (2421)
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Event Date 04/01/2019 |
Event Type
Injury
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Event Description
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Buxton k, morgan a, northam wt, stone ssd.Recurrent abdominal dislodgement of intrathecal pump and utility of infraclavicular site for patients with elevated body mass index: illustrative case.J neurosurg case lessons.2023;5(4):case22472.Doi:10.3171/case22472 reported events: 1 patient began experiencing increased leg pains, tone, and agitation.It was discovered volume of drug in the pump reservoir (40 ml) was higher than expected (19 ml) and cerebrospinal fluid could not be aspirated.A tight bend of the catheter in the abdominal pocket resulted in a catheter occlusion.The section of catheter had been replaced along with the pump.
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_cath, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a healthcare professional (hcp) reported the issue had begun in april, 2019.The healthcare professional also reported that they had felt the issues were related to the patient's positioning during different times of interacting with the patients pelvis/ribs causing the pump to flip.
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Search Alerts/Recalls
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