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Model Number 8637-40 |
Device Problems
Particulates (1451); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8703w, lot# l48278, implanted: (b)(6) 1998, explanted: (b)(6) 2020, product type catheter.Other relevant device(s) are: product id: 8703w, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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On 2020-may-05, information was received from an healthcare professional (hcp) regarding a patient receiving sufentanil (150 mcg/ml, 49.77 mcg/day), clonidine (1,000 mcg/ml, 331.8 mcg/day) and baclofen (330 mcg/ml, 109.4 mcg/day) via an implantable pump.It was reported the pump and catheter were replaced in january related to a reportable event.The hcp stated that the patient had a dye study and they were unable to aspirate the catheter access port (cap).The hcp stated that there were secretions in the catheter.
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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 was received from a health care provider on 2020-may-21.It was reported that the pump and catheter were replaced due to a catheter occlusion which required the revision.The pump was replaced at the same time.The patient's weight was not documented.No further complications were reported.
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Search Alerts/Recalls
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