Model Number V173 |
Device Problems
Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2024 |
Event Type
Injury
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Event Description
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It was reported that during a emergency room (er) visit, this cardiac resynchronization therapy pacemaker (crt-p) was discovered to be in safety mode.A procedure was performed and the crtp was explanted and successfully replaced with a new device.No additional adverse patient effects were reported.The device is expected to return for analysis.
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Event Description
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It was reported that during an emergency room (er) visit, this cardiac resynchronization therapy pacemaker (crt-p) was discovered to be in safety mode.The patient reported muscle stimulation at device pocket site.The crtp was evaluated and found to be in safety mode.A procedure was performed and the crtp was explanted and successfully replaced with a new device.No additional adverse patient effects were reported.The device is expected to return for analysis.
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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 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 during an emergency room (er) visit, this cardiac resynchronization therapy pacemaker (crt-p) was discovered to be in safety mode.The patient reported muscle stimulation at device pocket site.The crtp was evaluated and found to be in safety mode.A procedure was performed and the crtp was explanted and successfully replaced with a new device.No additional adverse patient effects were reported.The device is expected to return for analysis.
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Search Alerts/Recalls
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