SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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Model Number PLATINIUM DR 1540 |
Device Problems
Incorrect Measurement (1383); Failure to Transmit Record (1521)
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Patient Problem
No Information (3190)
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Event Date 09/05/2018 |
Event Type
malfunction
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Event Description
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Reportedly, on (b)(6) 2018, the follow-up center of the patient received an alert relative to atp therapy delivery.It was observed on the remote report that the displayed statistics for atrial pacing was superior to 100 %.The associated programmer source file was reviewed and the percentage of atrial pacing was 92%.On (b)(6) 2018, the patient called the center to report symptoms.A remote report transmission was initiated by the patient and the delivery of an atp therapy was observed.However, the center did not receive any alert relative to this atp.
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Manufacturer Narrative
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Please refer to the attached analysis report.- attachment: [20190109 - file-2018-03189 - analysis_and_closure_report_resp-2019-00028.Pdf].
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Event Description
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Reportedly, on (b)(6) 2018, the follow-up center of the patient received an alert relative to atp therapy delivery.It was observed on the remote report that the displayed statistics for atrial pacing was superior to 100 %.The associated programmer source file was reviewed and the percentage of atrial pacing was 92%.On 7 september 2018, the patient called the center to report symptoms.A remote report transmission was initiated by the patient and the delivery of an atp therapy was observed.However, the center did not receive any alert relative to this atp.
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Search Alerts/Recalls
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