Model Number LNQ11 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Blood Loss (2597)
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Event Date 05/23/2019 |
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 during the implantable cardiac monitor (icm) implant procedure, the patient would not stop bleeding.It was further reported that the icm header was bent during the implant procedure.The icm was explanted in order to obtain hemostasis.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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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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