Model Number PLATINIUM 4LV SONR CRT-D 1844 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Nausea (1970)
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Event Date 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, an inappropriate shock occurred during an af episode.The patient reported lipothymia and nausea and was hospitalized between (b)(6) 2021.
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Event Description
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Reportedly, an inappropriate shock occurred during an af episode.The patient reported lipothymia and nausea and was hospitalized between (b)(6) 2021.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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