Model Number MODEL 3000 |
Device Problems
Computer Software Problem (1112); Energy Output Problem (1431); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2020 |
Event Type
malfunction
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Event Description
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It was reported that the generator turned off unexpectedly and the patient could not feel stimulation.It was noted that this only happened once and the device was turned back on.The nurse practitioner does not recall a faulted diagnostic test occurring.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Event Description
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The patient's generator was replaced prophylactically.The explanted generator was discarded after surgery.No other relevant information has been received to date.
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Event Description
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Review of the physician's tablet data revealed that the change in settings was due to a faulted diagnostics test, which resulted in an inadvertent change in parameter settings.
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Search Alerts/Recalls
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