Model Number W173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 02/23/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient presented to the emergency department due to feeling phrenic nerve stimulation.It was discovered that the cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.Safety mode utilizes unipolar programming, which caused the patient's undesired stimulation sensations.The device was explanted and returned to boston scientific for analysis.No additional patient symptoms were reported.
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Event Description
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It was reported that the patient presented to the emergency department due to feeling phrenic nerve stimulation.It was discovered that the cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.Safety mode utilizes unipolar programming, which caused the patient's undesired stimulation sensations.The device was explanted and returned to boston scientific for analysis.No additional patient symptoms 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 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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