Model Number G158 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Staphylococcus Aureus (2058); Sepsis (2067)
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Event Date 08/09/2018 |
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.
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Event Description
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Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection with sepsis.It was also reported that the patient developed a staphylococcus bacteremia and septic arthritis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.
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Manufacturer Narrative
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Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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This supplemental report is being filed as updates from product investigation was received.Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection with sepsis.It was also reported that the patient developed a staphylococcus bacteremia and septic arthritis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.
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Search Alerts/Recalls
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