Model Number SC-1132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Unspecified Infection (1930); Swelling (2091)
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Event Date 11/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device remains implanted in patient.
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Event Description
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A report was received that the patient was hospitalized due to signs of infection.The patient underwent an operation in which their implant was cleansed and antibiotics were given to the patient.The patient has recovered and is now back home.Nothing was removed from the patient.
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Manufacturer Narrative
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A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
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Event Description
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A report was received that the patient was hospitalized due to signs of infection.The patient underwent an operation in which their implant was cleansed and antibiotics were given to the patient.The patient has recovered and is now back home.Nothing was removed from the patient.
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Search Alerts/Recalls
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