Model Number 0673 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Swelling (2091); No Code Available (3191)
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Event Date 10/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the product has not been returned.(b)(4).
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Event Description
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It was reported that this right ventricular (rv) lead was explanted due to infection.The patient underwent surgical intervention to explant the lead.No additional adverse patient effects were reported.The lead is not expected to return.
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Event Description
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It was reported that this right ventricular (rv) lead was explanted due to infection.The patient presented a fever and when checked, the pocked was swollen.The patient underwent surgical intervention to explant the lead.No additional adverse patient effects were reported.The lead is not expected to return.
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Manufacturer Narrative
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This supplemental report was filled to correct field b5: "describe event or problem", field e1: "initial reporter phone" and field h6: "patient codes".At this time, the product has not been returned.Patient code 3191 captures the reportable event of surgery.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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