Model Number CD3235-40Q |
Device Problems
Pacing Inadequately (1442); Under-Sensing (1661)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Undersensing was noted on the atrial lead during a follow-up appointment.The undersensing led to a decrease in biventricular pacing.The device was reprogrammed as an interim measure and the lead and icd replacement were planned.The patient was stable.No additional information was available.
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Event Description
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Undersensing was noted on the atrial lead during a follow-up appointment.The undersensing led to a decrease in biventricular pacing.The device was reprogrammed as an interim measure.The lead was capped and replaced, and the icd was replaced.The patient was well following the procedure.
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Search Alerts/Recalls
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