Model Number SC-1110-02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
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Event Date 02/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: sc-2218-50, serial/lot: (b)(4) and (b)(4), description: linear st lead kit 50 cm.Model: sc-4316, serial/lot: (b)(4), description: clik anchor.
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Event Description
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A report was received that the patient developed a hematoma near the ipg.The hematoma subsided however a wound appeared with drainage and opened where the ipg could be seen.The physician explanted the scs system as a precaution.The patient also developed a local infection which was treated with antibiotics.
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Event Description
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A report was received that the patient developed a hematoma near the ipg.The hematoma subsided however a wound appeared with drainage and opened where the ipg could be seen.The physician explanted the scs system as a precaution.The patient also developed a local infection which was treated with antibiotics.
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Manufacturer Narrative
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Additional information was received that the explanted devices were disposed by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
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Search Alerts/Recalls
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