MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Dyspnea (1816); Pleural Effusion (2010)
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Event Date 02/15/2019 |
Event Type
Injury
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Event Description
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It was reported that following a successful cryo ablation procedure, the patient had orthopnea and fluid overloading related to acute pulmonary edema.Residual right lower lobe (rll) patch was noted; thus, the patient was prophylactically administered an antibiotic.Discharge was to be arranged once the patient became stable and the pulmonary edema resolved; however, an x-ray later confirmed the patient had bilateral pulmonary effusion.Diuretic therapy was given to treat the effusion and was noted to have improved the patient's shortness of breath.The next day, a follow culture presented a few gram positive cocci indicating an infection was present and an antibiotic was administered.The patient was subjected to an extended hospitalization as a result of the event.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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.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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