Model Number V173 |
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 10/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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This investigation will be updated should further pertinent information be provided.
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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.Corrective actions were recommended as the patient is pacing dependent.It was noted that pacing inhibition occurred.At this time the crt-p has been explanted at a surgical intervention and returned for analysis.No additional adverse patient effects were reported.
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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.Corrective actions were recommended as the patient is pacing dependent.It was noted that pacing inhibition occurred.At this time the crt-p has been explanted at a surgical intervention and returned for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This investigation will be updated should further pertinent information be provided.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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