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Model Number PLATINIUM VR 1240 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Event Description
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Reportedly, shortly after implantation of the subject icd, a message was displayed to the user, stating that ventricular oversensing was suspected.In addition, at first interrogation of the device, a message about a necessary initialization appeared and was accepted by the user.
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Event Description
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Reportedly, shortly after implantation of the subject icd, a message was displayed to the user, stating that ventricular oversensing was suspected.In addition, at first interrogation of the device, a message about a necessary initialization appeared and was accepted by the user.
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Manufacturer Narrative
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Following additional questions received, the analysis report was updated.Please find attached the updated analysis report.
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Event Description
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Reportedly, shortly after implantation of the subject icd, a message was displayed to the user, stating that ventricular oversensing was suspected.In addition, at first interrogation of the device, a message about a necessary initialization appeared and was accepted by the user.
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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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