Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(4).
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This complaint is from a literature source.As reported in the literature publication entitled, ¿focal ventricular tachycardias in structural heart disease prevalence, characteristics, and clinical outcomes after catheter ablation¿.A (b)(6) years old male patient with structural heart disease (shd) who have focal ventricular tachycardia (vt) who underwent undergoing vt ablation developed anticipated complete heart block after extensive ablation to the substrate for vt involving the left basal septum with subsequent cardiac resynchronization therapy upgrade.
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