Model Number 1000 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that error code 6 (reset code) was detected on the patient's device with therapy disabled.Therapy for the patient was re-enabled and everything returned back to normal and the battery life and impedance were both ok.Internal data from the generator was received and reviewed.The device history records of the generator was reviewed.The generator passed final functional tests prior to distribution.No other relevant information has been received to date.
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Event Description
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Patient reported no longer being able to feel magnet stimulation and experiencing an increase in seizures.When the patient was seen in clinic, error code 6 was received upon interrogating the device.The patient's therapy was re-enabled and the patient could now feel stimulation.
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Manufacturer Narrative
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B6: relevant tests/laboratory data, including dates, corrected data: supplemental #01 report inadvertently left out relevant information.
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Event Description
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Additional information received from the patient noting that her device has disabled itself a total of 3 times since being implanted.
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Search Alerts/Recalls
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