Model Number V273 |
Device Problems
Over-Sensing (1438); 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 11/25/2023 |
Event Type
Injury
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Event Description
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It was reported that this device displayed safety mode and exhibited oversensing and under pacing due to unipolar configuration.This device was explanted and replaced with a different device.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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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/determined it had undergone resets and that bradycardia 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 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 device displayed safety mode and exhibited oversensing and underpacing due to unipolar configuration.This device was explanted and replaced with a different device.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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