Model Number K064 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker was explanted due to a product performance anomaly.The pacemaker was successfully replaced with a new device.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this pacemaker was explanted due to a product performance anomaly.The pacemaker was successfully replaced with a new device.No additional adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.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 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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Event Description
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It was reported that this pacemaker was explanted due to a product performance anomaly.The pacemaker was successfully replaced with a new device.No additional adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.
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Search Alerts/Recalls
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