Model Number V273 |
Device Problems
Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 12/14/2022 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The patient reported feeling muscle stimulation.This crt-p remains was explanted and successfully replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.It was confirmed that brady therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The patient reported feeling muscle stimulation.This crt-p was explanted and successfully replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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