Model Number MI2355A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Anemia (1706); Fever (1858); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Pain (1994); Dizziness (2194); Pallor (2468)
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Event Date 03/07/2020 |
Event Type
Injury
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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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It was reported that a few days after the leadless implantable pulse generator (ipg) implant procedure the patient presented with dizzy spells, low blood pressure, pallor, low fever and pain associated with a hematoma at the access site created by an introducer.The hematoma was drained.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further 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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Event Description
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It was further reported that patient became anemic as a result of the hematoma.Patient's anemia was treated with packed red blood cell transfusions.
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Search Alerts/Recalls
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