Model Number V173 |
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
Fall (1848); Head Injury (1879); Hemorrhage/Bleeding (1888); Syncope/Fainting (4411); Asystole (4442)
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Event Date 05/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.
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Event Description
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It was reported that this device declared a reset and transitioned into safety mode.Due to this mode switch, the sensing had a switch to unipolar, therefore noise was over-sensed.Pacing inhibition and asystole of five seconds were experienced.The patient passed out due to the asystole and hit the head.This caused bleeding.The generator has been explanted and a new device implanted at a surgical intervention procedure.No additional adverse patient effects were reported.
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Event Description
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It was reported that this device declared a reset and transitioned into safety mode.Due to this mode switch, the sensing had a switch to unipolar, therefore noise was over-sensed.Pacing inhibition and asystole of five seconds were experienced.The patient passed out due to the asystole and hit the head.This caused bleeding.The generator has been explanted and a new device implanted at a surgical intervention procedure.No additional adverse patient effects were reported.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.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 while communicating with the latitude remote monitoring system 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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