Model Number 24970A |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that at the beginning of an implant procedure, the analyzer was connected with pacing support in the background.Prior to the implant via the mobile programmer application, the analyzer froze and showed an hourglass.The user was unable to make any adjustments.A different programmer was used without any issue for completion of the procedure.It was noted that the user swiped everything closed prior to set up in order to have a fresh start with the application.The device is still in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: it was determined at analysis that in pacing system analyzer lead analysis, the 'parameter change not confirmed' was displayed when the lower rate was tried to program.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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