Model Number V273 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
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.Loss of atrio ventricular synchrony was reported.Technical services (ts) was consulted and recommended device replacement.This crt-p remains in service.No adverse patient effects were reported.Additional information was received and this crt-p was explanted and replaced.No additional adverse patient effects were reported.This product has not returned for analysis.
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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.Interrogation of the device confirmed that bradycardia 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 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.Loss of atrio ventricular synchrony was reported.Technical services (ts) was consulted and recommended device replacement.This crt-p remains in service.No adverse patient effects were reported.Additional information was received and this crt-p was explanted and replaced.No additional adverse patient effects were reported.This product has returned for analysis.
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Search Alerts/Recalls
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