SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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Model Number ISOLINE 2CR6 |
Device Problems
Defibrillation/Stimulation Problem (1573); Low impedance (2285)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 02/12/2015 |
Event Type
Injury
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Event Description
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During a scheduled patient follow-up (for cardioversion purpose), the user programmed an induction shock at 20j from the eps screen, but the shock was not delivered (the patient did not feel the shock) and the atrial fibrillation was still observed.A warning message was displayed to the user stating that ¿low shock impedance.Defibrillation system ineffective¿.Three more attempts with maximum energy shock (at 42j) had failed again because of overload phenomenon.It should be noted that all impedance and continuity measurements were normal and the battery was still far from elective replacement indicator (eri at 2.66v), and a problem with the associated icd is not suspected.Recommendations to evaluate the benefit of a lead replacement were provided by the manufacturer, and a re-intervention was subsequently performed to correct the issue.
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Event Description
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During a scheduled patient follow-up (for cardioversion purpose), the user programmed an induction shock at 20j from the eps screen, but the shock was not delivered (the patient did not feel the shock) and the atrial fibrillation was still observed.A warning message was displayed to the user stating that ¿low shock impedance.Defibrillation system ineffective.¿ three more attempts with maximum energy shock (at 42j) had failed again because of overload phenomenon.It should be noted that all impedance and continuity measurements were normal and the battery was still far from elective replacement indicator (eri at 2.66v), and a problem with the associated icd is not suspected.Recommendations to evaluate the benefit of a lead replacement were provided by the manufacturer, and a re-intervention was subsequently performed to correct the issue.
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