Model Number G148 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Unspecified Infection (1930); Pain (1994); Discharge (2225)
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Event Date 09/08/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 product was part of a system revision due to infection.The patient reported experiencing erythema, edema, drainage and pain around the device insertion site.There were no additional adverse effects reported.The product was explanted.
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Manufacturer Narrative
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--.
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Event Description
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Additional information received indicates that the cultures obtained from the patient tested positive for (b)(6) infection.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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