Model Number SC-1132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Edema (1820)
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Event Date 09/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model#: sc-2352-50 serial #: (b)(4) description: linear 3-4 lead, 50cm.
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Event Description
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A report was received that the patient was experiencing mild bilateral lower extremity (ble) edema and mottling of the skin over the right hip and thigh.No device malfunction was suspected by the physician.The patient will undergo an explant procedure.
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Manufacturer Narrative
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Additional information was received that the patient underwent an explant procedure.The explanted devices were not returned to bsn.
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Event Description
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A report was received that the patient was experiencing mild bilateral lower extremity (ble) edema and mottling of the skin over the right hip and thigh.No device malfunction was suspected by the physician.The patient will undergo an explant procedure.
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Search Alerts/Recalls
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