Model Number SC-1132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); No Code Available (3191)
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Event Date 01/15/2020 |
Event Type
Injury
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Event Description
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A report was received that the patients ipg was beginning to protrude through the skin and was becoming red and painful.It was noted that the patient had an infection and inflammatory reaction due to other nervous system device, implant or graft.The patient was prescribed with medication for pain management and as prophylaxis against infection at the ipg site.
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Manufacturer Narrative
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Model number/catalog number: sc-2316-50 serial number: (b)(6).Batch/lot number: 18437628/18915135.Model/catalog description: infinion lead kit, 50 cm.Additional information was received that the patients infection was at the ipg site.The physician confirmed that it was not device or procedure related.The infection may be due to a poor surgical technique from a different physician.The patient was prescribed with antibiotics and underwent an explant procedure.The patient was doing well postoperatively.The explanted devices were not returned to bsn as they were discarded by the medical facility.
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Event Description
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A report was received that the patients ipg was beginning to protrude through the skin and was becoming red and painful.It was noted that the patient had an infection and inflammatory reaction due to other nervous system device, implant or graft.The patient was prescribed with medication for pain management and as prophylaxis against infection at the ipg site.
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Search Alerts/Recalls
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