Model Number SC-1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Unspecified Infection (1930); Discomfort (2330); Diaphoresis (2452)
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Event Date 06/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: exact date unknown, event occurred few weeks after the implant date.
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Event Description
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It was reported that the patient developed an infection in an unknown location.The patient underwent an explant procedure.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: scs-linear leads-mri; upn: m365sc2408560; model: sc-2408-56; serial: (b)(6); batch: 5149949/5155895.
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Event Description
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It was reported that the patient developed an infection in an unknown location.The patient underwent an explant procedure.Additional information was received that the patient developed an infection at the incision site.Symptoms of tenderness, soreness, and sweating were noted.After sneezing, the patient felt like the stitch ripped out.The physician believed that the infection was not device related.The patient was placed on antibiotics and all components were explanted and discarded.
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Search Alerts/Recalls
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