Model Number PLATINIUM CRT-D 1711 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/01/2018 |
Event Type
Injury
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Event Description
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Reportedly, the patient is pacemaker-dependent after av node modulation.Since this device is subject to the field safety notice issued in (b)(6) 2018, it was prophylactically replaced.Preliminary analysis results did not reveal any device malfunction.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Reportedly, the patient is pacemaker-dependent after av node modulation.Since this device is subject to the field safety notice issued in july 2018, it was prophylactically replaced.Preliminary analysis results did not reveal any device malfunction.
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Search Alerts/Recalls
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