Model Number SC-1160 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); No Code Available (3191)
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Event Date 07/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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Model number/catalog number: sc-2218-50.Serial number: (b)(4).Batch/lot number: 16121539/ 16065047.Model/catalog description: linear st lead kit 50 cm.
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Event Description
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It was reported that the patient had an infection.The patient underwent an explant procedure.
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Manufacturer Narrative
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Additional information was received that the patient infection was on the battery site.Symptoms of puffiness and swelling were noted.The patient was placed on antibiotics.
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Event Description
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It was reported that the patient had an infection.The patient underwent an explant of the scs system.
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Search Alerts/Recalls
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