Model Number ORCHESTRA PLUS |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
Not Applicable (3189)
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Event Date 10/27/2015 |
Event Type
malfunction
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Event Description
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A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date (31/12/9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is required.
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Manufacturer Narrative
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Preliminary analysis showed that having the follow-up date as an implantation date when no patient data are programmed is the intended behavior.However, the (b)(6) 1999 date observed is a display anomaly that concerns the symphony devices family.
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Event Description
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A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date ((b)(6) 9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is required.
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Manufacturer Narrative
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Please refer to the attached analysis report.(b)(4).
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Event Description
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A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date (31/12/9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is required.
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Search Alerts/Recalls
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