Information was received from a healthcare provider (hcp) regarding a patient receiving baclofen (2000 mcg/ml at 1500 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.The hcp reported that there was a catheter connection failure for a while now, so the patient had not been getting therapy.The hcp did not know when it happened.The pump had also been stalled for more than 48 hours.The hcp was requesting the pump off passcode to permanently stop the pump because the pump was also due for eri (elective replacement indicator) soon, so they were just going to shut it off.
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Concomitant medical products: product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2009 product type catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 11-sep-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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