BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G447 |
Device Problems
Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Read Input Signal (1581); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded low intrinsic amplitude out of range measurement in both right ventricular (rv) and left ventricular (lv).Also, on the same day of the low amplitude measurement, noisy egm and fusion behavior were observed.An alert was detected for left ventricular automatic threshold (lvat) greater than programmed amplitude or suspended and high threshold measurement was noted on the lv lead.An x-ray was performed and found no anomaly.Boston scientific technical services recommended in-clinic testing, additional troubleshooting, and aim to evaluate lead mechanical integrity and lead stability.No adverse patient effects were reported.This device, rv lead and competitor lv lead remains in-service.
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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.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded low intrinsic amplitude out of range measurement in both right ventricular (rv) and left ventricular (lv).Also, on the same day of the low amplitude measurement, noisy egm and fusion behavior were observed.An alert was detected for left ventricular automatic threshold (lvat) greater than programmed amplitude or suspended and high threshold measurement was noted on the lv lead.An x-ray was performed and found no anomaly.Boston scientific technical services recommended in-clinic testing, additional troubleshooting, and aim to evaluate lead mechanical integrity and lead stability.No adverse patient effects were reported.This device, rv lead and competitor lv lead remains in-service.
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Search Alerts/Recalls
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