Model Number K174 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Dyspnea (1816); Device Overstimulation of Tissue (1991); Syncope/Fainting (4411)
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Event Date 12/02/2022 |
Event Type
Injury
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Event Description
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It was reported that this implantable pulse generator (pacemaker) switched into safety mode, a device status that permanently limits available therapy to specific settings.Technical services recommended to replace this device as soon as possible as critical therapy cannot be guaranteed.The patient suffered muscle stimulation, dyspnea and syncope due to this issue.Subsequently, this pacemaker was explanted, replaced and it is expected to be returned for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If the product is returned, analysis would be performed, and this report would be updated at that time.
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Manufacturer Narrative
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If the product is returned, analysis would be performed, and this report would be updated at that time.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 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 this implantable pulse generator (pacemaker) switched into safety mode, a device status that permanently limits available therapy to specific settings.Technical services recommended to replace this device as soon as possible as critical therapy cannot be guaranteed.The patient suffered muscle stimulation, dyspnea and syncope due to this issue.Subsequently, this pacemaker was explanted, replaced and was returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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