Model Number 419688 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiopulmonary Arrest (1765); Death (1802); Encephalopathy (1833); Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Lethargy (2560)
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Event Date 02/07/2019 |
Event Type
Death
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Manufacturer Narrative
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Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2007.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 that the patient was admitted with hypotension in an altered mental state due to subacute infective endocarditis and bacteremia.The patient was treated with intravenous antibiotics and was discharged to a transitional care unit (tcu).The patient was later readmitted from the tcu due to lethargy and unresponsiveness due to multifactorial metabolic encephalopathy.The patient's family decided to transition the patient to comfort care only and had the cardiac resynchronization therapy defibrillator (crt-d) system detections and therapies programmed off.The patient expired the following day with the primary cause of death being reported as cardiopulmonary arrest.The patient was a participant in the (b)(6) registry.No further information was reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Blood cultures showed enterococcus faecalis and a transesophageal echocardiogram (tee) showed vegetation on the tricuspid valve.The physician felt that the system should have been explanted.
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Search Alerts/Recalls
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