Model Number V173 |
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 12/11/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered into safety mode and was recommended to be explanted.There was over sensing and pacing inhibition.At this time the crt-p has been explanted and has been returned for analysis.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.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 while communicating with the latitude remote monitoring system and other transient elevated power states 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 cardiac resynchronization therapy pacemaker (crt-p) entered into safety mode and was recommended to be explanted.There was over sensing and pacing inhibition.At this time the crt-p has been explanted and has been returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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