Model Number SC-1160 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Edema (1820); Unspecified Infection (1930); No Code Available (3191)
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Event Date 04/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Model number/ catalog number: sc-8336-50, serial number: (b)(4), batch/ lot number: 7055854, model/ catalog description: coverdege 32 surgical lead kit 50 cm.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 had an infection.The patient underwent a spinal cord stimulator (scs) explant procedure.
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Event Description
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A report was received that the patient had an infection.The patient underwent a spinal cord stimulator (scs) explant procedure.
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Manufacturer Narrative
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Additional information was received that the location of the infection was at the lead incision site.There was swelling noted near the midline incision site.It was unknown what caused the infection.The patient was placed on antibiotics.
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Search Alerts/Recalls
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