SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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Model Number ISOLINE 2CR6 |
Device Problems
Nonstandard Device (1420); Over-Sensing (1438); Pacing Intermittently (1443); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
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Patient Problem
No Information (3190)
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Event Date 03/07/2019 |
Event Type
Injury
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Event Description
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Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.
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Manufacturer Narrative
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Reportedly, a re-intervention was performed to replace the associated icd and atrial lead.
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Event Description
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Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.
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Event Description
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Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.
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Search Alerts/Recalls
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