ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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Model Number CD3369-40Q |
Device Problems
Over-Sensing (1438); Pacing Problem (1439)
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Patient Problems
Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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It was reported that the patient presented to the emergency room experiencing vomiting and bradycardia.Upon interrogation, it was noted that the implantable cardioverter defibrillator - icd exhibited inappropriate rate decrease and t-wave oversensing.The icd was reprogrammed and the patient was in stable condition.
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Search Alerts/Recalls
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