Model Number G140 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
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Event Date 01/06/2016 |
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 product was part of a system revision due to infection.There were no additional adverse patient 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 patient claimed that their device had eroded.A potential allergic reaction to the device was also initially suspected.Further information received from the field representative noted that the physician did not think there was an allergic reaction and that the erosion was most likely due to a hematoma.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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