Model Number 4671 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Fever (1858); Staphylococcus Aureus (2058); Sepsis (2067); Impaired Healing (2378); No Code Available (3191)
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Event Date 02/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.(b)(4).
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Event Description
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It was reported that this left ventricular (lv) lead was part of a system revision due to pocket infection.Additional information received indicates that the patient presented to the hospital with fever and was initially ruled out for subsequently demonstrated staphylococcus aureus and sepsis.The patient also complained of having issues with the incision healing, stitch abscess and purulent discharge from the site.The pocket was flushed with antibiotic solution.There were no additional adverse patient effects reported.The lv lead was explanted.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Patient code 3191 captures the reportable event of surgery and the additional intervention treatment with the use of antibiotic solution.Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the returned lv lead was analyzed and visually inspected in which the lead exhibited normal characteristics and revealed no abnormalities.This supplemental is being filed to capture the product analysis from the product investigation.
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Event Description
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It was reported that this left ventricular (lv) lead was part of a system revision due to pocket infection.Additional information received indicates that the patient presented to the hospital with fever and was initially ruled out for subsequently demonstrated staphylococcus aureus and sepsis.The patient also complained of having issues with the incision healing, stitch abscess and purulent discharge from the site.The pocket was flushed with antibiotic solution.There were no additional adverse patient effects reported.The lv lead was explanted.
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Search Alerts/Recalls
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