Model Number MODEL 3000 |
Device Problems
Computer Software Problem (1112); Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2019 |
Event Type
malfunction
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Event Description
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It was reported that the patient was going to have their generator replaced for an unknown reason.Information was later received that the replacement would be due to prophylactic reasons, neos, and that the patient was "on a rapid cycle protocol + high lead impedances.No known surgery has occurred to date.No additional, relevant information was received to date.
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Event Description
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Patient underwent generator replacement surgery.Impedance was confirmed to be ok after generator replacement and pre-operative impedance was ok with version 1.0 software being used to perform the diagnostics.The explanted generator has not been received by product analysis to date.For model 102/102r generators programmed to output currents > 1 ma , it was observed that system diagnostics using m3000 v1.0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1.5 software would display a false high impedance.
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Event Description
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Confirmation was received from the physician's office that version 1.5 software was used when the high impedance was observed.The output currents were confirmed to be >0ma when the high impedance was observed.
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Event Description
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Further information was received that the explanted generator was discarded after surgery.
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Event Description
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Follow up with the physician's office clarified when the high impedance was first seen and confirmed that the high impedance was seen on a system diagnostics as an impedance range was provided, indicating that the diagnostic was performed on the newer programming systems which do not provide impedance ranges for normal mode diagnostics.No additional, relevant information was received to date.
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Search Alerts/Recalls
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