Concomitant medical products: product id: 8731sc, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 10-jan-2011, udi#: (b)(4).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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Information was received from a consumer via a manufacturer representative regarding a patient who was receiving dilaudid (hydromor phone) (did not ask mg/ml at did not ask mg/day), bupivacaine (did not ask mg/ml at did not ask mg/day), and clonidine (did not ask mcg/ml at did not ask mcg/day) via an implantable pump for spinal pain indications.It was reported that patient was scheduled to have the pump/catheter replaced on (b)(6) 2022 because "for about the last 2 years" there has been something wrong with either the catheter or the pump" troubleshooting was not required.The issue was not resolved as troubleshooting was not needed.The patient was redirected to their healthcare provider to further address the issue.
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