Model Number 459888 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pleural Effusion (2010)
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Event Date 05/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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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 that the day after the implant, the patient was found to have a small to moderate pleural effusion.The patient's medications were adjusted and the leads remain in use.The patient is a participant in the (b)(6) study.No patient complications have been reported as a result of this event.
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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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Search Alerts/Recalls
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