MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical devices: product id: 8711, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: 13-may-2010, 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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Information was received from a healthcare provider via a manufacturer's representative regarding a patient receiving unknown drug via an implanted pump.It was reported the patient had a catheter dye study that failed.The patient was not having symptoms so the catheter was not replaced.Following a normal pump replacement, the patient started experiencing symptoms of "sympathetic overdrive.¿ the clinic tried giving boluses and changing doses.The decision was made to replace the catheter.During the catheter replacement today the catheter was not able to be aspirated so it was replaced with an 8780 catheter.It was a portion of the catheter was removed the spinal segment was left in place and tied off.
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Manufacturer Narrative
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Continuation of d10: product id: 8711, lot#/serial#: (b)(6), implanted: (b)(6) 2008, explanted: (b)(6) 2020, product type: catheter.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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Search Alerts/Recalls
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