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Model Number MI2355A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/29/2021 |
Event Type
malfunction
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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 during implant of a leadless implantable pulse generator (ipg), after introduction of the introducer, negative pressure suction was carried out and repeated suction was performed more than ten times and all failed.It was further reported that the hemostasis valve was unable to close.Another introducer was used and the leadless ipg was implanted. no further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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