MEDTRONIC EUROPE SARL AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMB1D1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Septic Shock (2068)
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Event Date 02/17/2024 |
Event Type
Death
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Event Description
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It was reported that the patient with a cardiac resynchronization therapy defibrillator (crt-d) system was admitted to the hospital due to septic shock.The patient passed away due to non-cardiac issues.
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Manufacturer Narrative
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Continuation of d10: 419488, lead; implanted: (b)(6) 2007.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additionally, the clinic disclosed that the source of the septic shock was gastrointestinal bleed; e-coli bacteremia; left obstructive uropathy with severe hydronephrosis, and hematuria.The cause of death listed as septic shock; cardiogenic shock; neurogenic shock; compression of brain due to spontaneous cerebral hemorrhage, and erosive gastritis with hemorrhage.
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