MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA1D4 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Erythema (1840); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Heart Block (4444); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 11/29/2023 |
Event Type
Death
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Manufacturer Narrative
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Continuation of d10: mc2avr1 leadless pacemaker implanted: (b)(6) 2023 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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It was reported the patient developed swelling at the cardiac resynchronization therapy defibrillator (crt-d) site approximately four years post device implant.The patient then developed a blister at the site.An infection was suspected and the source of the infection was noted related to an infected chemotherapy port.A leadless implantable pulse generator (ipg) was placed.During the crtd system explant the patient coded, pulseless electrical activity was observed and a right atrial clot was observed via transesophageal echocardiogram (tee) resulting in bilateral pulmonary embolism.An embolectomy was performed.Resuscitation was performed and the patient required vasopressor support however, despite maximum doses could not sustain an adequate blood pressure.The patient was transferred to the intensive care unit (icu) where they passed away.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was further reported that the patient is a participant in a clinical study.
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Search Alerts/Recalls
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