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Model Number CDDRA500Q |
Device Problem
Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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Related manufacturer reference number: 2017865-2021-40542.It was reported during capture threshold testing, the user released the button to terminate the testing on the merlin programmer as expected, however, the patient's implantable cardioverter-defibrillator continued to decrement, resulting in loss of capture.No interventions were reported.The patient was stable.
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Event Description
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It was reported that the patient presented in clinic after a parameter-out-of-range alert was seen on the implantable cardioverter defibrillator (icd).Upon interrogation, it did not appear that the error message was resolved and it was determined the invalid diagnostic issue could only be resolved with the future software release.Then, during capture threshold testing, the user released the button to terminate the testing on the merlin programmer as expected, but the capture test did not terminate and continued to decrement.The patient did not experience any symptoms due to this event.When the capture testing was repeated, it was completed without difficulty.No interventions were performed.The patient was in stable condition.
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Search Alerts/Recalls
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