BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U228 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2021 |
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.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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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited increasing impedance measurements until it triggered a lead safety switch (lss) due to a high out-of-range lv pace impedance measurement of 2021 ohms.It was noted that the presenting electrogram (egm) appeared similar to the previous presenting egm, but now lv pacing is in unipolar.Technical services (ts) discussed possible options including reprogramming, assessing other vectors, and increasing the lv impedance alert value.This crt-p and the leads remain in service at this time.No adverse patient effects were reported.
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Search Alerts/Recalls
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