MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPA2QQ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 03/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: lda220q58 lead implanted: (b)(6) 2015 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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It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) system the patient encountered purulent discharge, pus, redness, swelling and a suspected infection was noted. a antibacterial absorbable envelope was implanted and the crt-d system remains in use. no further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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