Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 05/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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This investigation will be updated should further pertinent information be provided.Pending conclusion.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered an alert for safety mode.The patient is getting muscle stimulation due to polarity change in left ventricular (lv) lead pacing as a result of the safety mode.The patient does not appear dependent as intrinsic amplitudes were available from last in clinic check.The device was recommended to be explanted and has been explanted at this time.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) triggered an alert for safety mode.The patient is getting muscle stimulation due to polarity change in left ventricular (lv) lead pacing as a result of the safety mode.The patient does not appear dependent as intrinsic amplitudes were available from last in clinic check.The device was recommended to be explanted and has been explanted at this time.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 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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