Model Number CD3357-40Q |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959); Wireless Communication Problem (3283)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 06/22/2020 |
Event Type
Injury
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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 inappropriate shock.Upon interrogation, it was noted that the implantable cardioverter defibrillator was in backup vvi and had caused inappropriate shock due to misdiagnosis of supraventricular tachycardia as ventricular tachycardia.It was noted that the electrocardiogram could not be recovered and that the transmission was slow.The icd was reprogrammed (b)(6) 2020.The patient was in stable condition after the programming changes were made.
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Search Alerts/Recalls
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