Model Number D140 |
Device Problem
Failure to Convert Rhythm (1540)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that this single chamber implantable cardioverter defibrillator (icd) and associated right ventricular (rv) lead were implanted.During defibrillation threshold (dft) testing, the patient was induced but the delivered shocks did not convert the ventricular fibrillation (vf) and external shocks were required.During the first induction, the lead was located mid-septal, and a 21 joule, 31 j, and 41 j shock all failed to convert.Shock impedances were normal, at 62-64 ohms.The rhythm was converted with an external shock and the lead was repositioned to an apical location.During the second induction, two 41 joule shocks failed to convert and another external shock was delivered.A third induction was tried where one 41 joule shock was delivered and failed so another external shock was needed.At this point, the physician explanted and boston scientific lead and device and implanted a competitor's system, where the first induction was successfully converted with a 35 joule shock.Technical services discussed there could be many contributing factors, such as lead position, the number of inductions, and the length of procedure/sedation.The sales representative noted local anesthesia is used for implant procedure and propofol (an anesthetic and a sedative) for the dft testing.No adverse patient effects were reported.The explanted device and lead were expected to be returned for analysis.
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Manufacturer Narrative
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The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Manufacturer Narrative
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The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the failure to convert an induced arrhythmia the occurred during the implant procedure.
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Event Description
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It was reported that this single chamber implantable cardioverter defibrillator (icd) and associated right ventricular (rv) lead were implanted.During defibrillation threshold (dft) testing, the patient was induced but the delivered shocks did not convert the ventricular fibrillation (vf) and external shocks were required.During the first induction, the lead was located mid-septal, and a 21 joule, 31 j, and 41 j shock all failed to convert.Shock impedances were normal, at 62-64 ohms.The rhythm was converted with an external shock and the lead was repositioned to an apical location.During the second induction, two 41 joule shocks failed to convert and another external shock was delivered.A third induction was tried where one 41 joule shock was delivered and failed so another external shock was needed.At this point, the physician explanted the boston scientific lead and device and implanted a competitor's system, where the first induction was successfully converted with a 35 joule shock.Technical services discussed there could be many contributing factors, such as lead position, the number of inductions, and the length of procedure/sedation.The sales representative noted local anesthesia is used for implant procedure and propofol (an anesthetic and a sedative) for the dft testing.No adverse patient effects were reported.The explanted device and lead were expected to be returned for analysis.Reference report number 2124215-2023-19435 for the associated lead.
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Search Alerts/Recalls
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