BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U125 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
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Patient Problem
Muscle Stimulation (1412)
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Event Date 05/29/2020 |
Event Type
malfunction
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Event Description
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It was reported that there was one jump in right ventricular (rv) lead pace impedance.The measurement was greater than 3000 ohms.Muscle noise oversensing occurred as a result of the impedance jump, as the pacing configuration automatically switched to unipolar pacing.The patient reported feeling stimulation.The health care professional (hcp) was going to bring the patient in for impedance testing.No adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.
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Manufacturer Narrative
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The evaluation conclusion code was updated.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.
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Event Description
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It was reported that there was one jump in right ventricular (rv) lead pace impedance.The measurement was greater than 3000 ohms.Muscle noise oversensing occurred as a result of the impedance jump, as the pacing configuration automatically switched to unipolar pacing.The patient reported feeling stimulation.The health care professional (hcp) was going to bring the patient in for impedance testing.No adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.
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Search Alerts/Recalls
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