Model Number SC-1110-02 |
Device Problems
Device Inoperable (1663); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2018 |
Event Type
Injury
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Event Description
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A report was received that the patients ipg was non-functional.The patient will undergo a revision procedure.
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Manufacturer Narrative
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Additional information was received that the patients ipg was using more battery power and was charging frequently.The patient will undergo an ipg replacement procedure.
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Event Description
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A report was received that the patients ipg was non-functional.The patient will undergo a revision procedure.
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Manufacturer Narrative
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Additional information was received that there will be no further course of action at this time.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.
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Event Description
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A report was received that the patients ipg was non-functional.The patient will undergo a revision procedure.
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Search Alerts/Recalls
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