Model Number V273 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Syncope/Fainting (4411); Asystole (4442)
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Event Date 05/03/2023 |
Event Type
Injury
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Event Description
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It was reported that this implantable pacemaker entered in safety mode, due to this myopotential noise, oversensing and pacing inhibition of over six seconds was observed and the patient experienced a syncope episode.It was decided to explant and replace this device.This device is expected to be returned for analysis.No further adverse patient effects were reported.
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Event Description
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It was reported that this implantable pacemaker entered in safety mode, due to this myopotential noise, oversensing and pacing inhibition of over six seconds was observed and the patient experienced a syncope episode.It was decided to explant and replace this device.This device is expected to be returned for analysis.No further 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.Interrogation of the device confirmed it was operating in safety mode due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.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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Search Alerts/Recalls
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