Model Number MODEL 3000 |
Device Problems
False Alarm (1013); Fracture (1260); Application Program Problem: Parameter Calculation Error (1449)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/07/2019 |
Event Type
malfunction
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Event Description
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Programming history database periodic review was performed and confirmed a high impedance event for the patient.High impedance was seen on.Patient underwent generator replacement but no known lead replacement has occurred to date.No additional relevant information has been received to date.
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Event Description
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High impedance was observed when v1.5 software was used on a m102 generator.System diagnostics were initially performed which caused the false high impedance to be observed.The impedance was likely stored from the previous system diagnostics.It was determined that the cause of this false high impedance message was a software error on m3000 v1.5.2.1 software; when system diagnostics were performed by the user with m3000 v1.5.2.1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead.The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds.No additional relevant information has been received to date.
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Manufacturer Narrative
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B5.Corrected information, section d corrected information; information inadvertently omitted that was known prior to submission of mdr.
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Search Alerts/Recalls
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