BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U128 |
Device Problems
Failure to Capture (1081); Interrogation Problem (4017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that during this right ventricular automatic threshold (rvat) testing, this patient experienced a period of six to ten seconds of asystole.The caller reported a cancelled message on the electrograms and telemetry was intermittent.A boston scientific technical services consultant discussed that telemetry interference could have caused the test to register cancelled but the device kept going with the test until telemetry was lost or regained.No adverse patient effects were reported.
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Search Alerts/Recalls
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