Model Number SMARTVIEW REMOTE MONITORING WEBSITE |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
Event Type
malfunction
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Event Description
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Reportedly, the complaint is regarding remote follow-up transmission report in german.On the (b)(6) 2023, a transmission occurred, with a red alert because of a high right ventricular threshold.- the message under warnings shows wrong values.- the transmission from the (b)(6) 2023 shows the same wrong values when the electrode status is "green" and "ok" although the right ventricular threshold was unsuccessful.- in both transmissions, the translation of the time to rrt is in a wrong language.
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Event Description
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Reportedly, the complaint is regarding remote fu transmission report.On the (b)(6) a transmission took place, with a red alert because of a high rv threshold.- the message under warnings shows wrong values.(({0:s} v)) - the transmission from the (b)(6) shows the same wrong values under warning.(({0:s} v)) also, the electrodes are "green" and "ok" although the rv threshold was unsuccessful.- in both transmissions, the time to rrt is in the wrong language."tempo hasta rrt" instead of the german equivalent.This appears to be with most pacemaker remote transmissions.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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