SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number REPLY DR |
Device Problem
Failure to Transmit Record (1521)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/16/2014 |
Event Type
Death
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Event Description
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Reportedly, a ventricular tachycardia event was observed on (b)(6) 2014 (on the ecg monitor in the care unit).However, no corresponding episode was observed in the device memory upon interrogation.An analysis is requested.
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Event Description
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Reportedly, during the follow-up performed on (b)(6) 2014, the patient had a ventricular tachycardia (as observed on monitors in the care unit).However no v burst episode was recorded in device memory.An analysis is requested.
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Event Description
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Reportedly, a ventricular tachycardia event was observed on (b)(6) 2014 (on the ecg monitor in the care unit).However no corresponding episode was observed in the device memory upon interrogation.An analysis is requested.
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