Model Number SC-1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Staphylococcus Aureus (2058); Fluid Discharge (2686); No Code Available (3191)
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Event Date 10/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patients implant site was draining.The patient was prescribed with antibiotics.No further course of action will be taken at this time.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: scs-paddle leads; upn: m365sc8216500; model: sc-8216-50; serial: (b)(4); batch: 7070390l.
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Event Description
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It was reported that the patients implant site was draining.The patient was prescribed with antibiotics.No further course of action will be taken at this time.Additional information was received that the patient was not infected.The patient was reprogrammed and is currently doing well.Additional information was received that all components were explanted and discarded.The patient was doing well postoperatively.
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Event Description
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It was reported that the patients implant site was draining.The patient was prescribed with antibiotics.No further course of action will be taken at this time.Additional information was received that the patient was not infected.The patient was reprogrammed and is currently doing well.
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Search Alerts/Recalls
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