Model Number K184 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient implanted with this pacemaker presented to the hospital for an unrelated surgery.Interrogation of the device with a programmer prior to the surgery noted the device had reverted to safety mode.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the product is expected.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Event Description
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It was reported that the patient implanted with this pacemaker presented to the hospital for an unrelated surgery.Interrogation of the device with a programmer prior to the surgery noted the device had reverted to safety mode.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the product is expected.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The product has been received 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 determined it had undergone resets 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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Search Alerts/Recalls
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