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
Failure to Capture (1081)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/27/2021 |
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.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker was exhibiting loss of capture on an external monitor.
The available holter strips were reviewed by boston scientific technical services and confirmed there was loss of capture but there was no evidence of loss of capture from the device available information.
Additionally, the patient was seen in-clinic for a follow up.
The lead testing met specification and there was no evidence of any anomaly.
The cardiologist will make device reprogramming changes if needed.
No adverse patient effects were reported.
This device remains in service.
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Search Alerts/Recalls
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