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
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right atrial (ra) lead, had triggered a lead safety switch (lss) due to a high out-of-range pace impedance measurement greater than 3,000 ohms.Following the lss, noise with oversensing was observed on the ra channel.Technical services (ts) recommended further lead evaluation with isometrics and pocket manipulations to determine event cause.This crt-d and ra lead remain in service.No adverse patient effects were reported.
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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.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
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Search Alerts/Recalls
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