BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U128 |
Device Problem
High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 the right ventricular (rv) lead connected to this cardiac resynchronization therapy pacemaker (crt-p), has had a high and variable pace impedance.The rv lead is from another manufacturer.The highest recorded measurement was within normal limits and there were no episodes with noise.Technical services suggested troubleshooting.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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