Model Number SC-1200 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Staphylococcus Aureus (2058)
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Event Date 09/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model #: sc-2408-56 serial #:(b)(4), description: avista mri perc lead kit, 56 cm.
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Event Description
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A report was received that the patient was experiencing chronic infection at the midline incision site.Symptoms of purulent discharge and erythema were noted at the inferior aspect of the midline incision.The patient was weaned down on antibiotics and developed a chronic stitch small abscess which was drained.The patient will undergo a revision procedure wherein the leads will be replaced.
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Manufacturer Narrative
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Additional information was received that the physician believed that the infection was not device related and the cause of infection was unknown.The physician also did not suspect anything from the recent procedure that would have contributed to the infection.The patient underwent an explant procedure and was reportedly doing well postoperatively.
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Event Description
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A report was received that the patient was experiencing chronic infection at the midline incision site.Symptoms of purulent discharge and erythema were noted at the inferior aspect of the midline incision.The patient was weaned down on antibiotics and developed a chronic stitch small abscess which was drained.The patient will undergo a revision procedure wherein the leads will be replaced.
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Manufacturer Narrative
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The explanted devices were not returned to bsn.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
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Event Description
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A report was received that the patient was experiencing chronic infection at the midline incision site.Symptoms of purulent discharge and erythema were noted at the inferior aspect of the midline incision.The patient was weaned down on antibiotics and developed a chronic stitch small abscess which was drained.The patient will undergo a revision procedure wherein the leads will be replaced.
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Search Alerts/Recalls
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