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Model Number KORA 250 DR |
Device Problem
Pacing Inadequately (1442)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, during a routine follow-up, the doctor noticed inappropriate spikes when recording the ecg.The doctor called us to interrogate the patient and during the follow-up, everything was normal: proper sensing and capture in the 2 cavities was observed, there was not any particular event in the memories.In addition, when launching the egm on another orchestra plus programmer, no anomaly was observed.There was only one atrial extra systole, which led to atrial pacing where it was not necessary.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Reportedly, during a routine follow-up, the doctor noticed inappropriate spikes when recording the ecg.The doctor called us to interrogate the patient and during the follow-up, everything was normal: proper sensing and capture in the 2 cavities was observed, there was not any particular event in the memories.In addition, when launching the egm on another orchestra plus programmer, no anomaly was observed.There was only one atrial extra systole, which led to atrial pacing where it was not necessary.
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Search Alerts/Recalls
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