Model Number K087 |
Device Problems
Premature Discharge of Battery (1057); Failure to Capture (1081); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient implanted with this pacemaker was admitted to the hospital.Review of external monitoring equipment noted pacing spikes at a fixed rate of 72 paces per minute (ppm) with no corresponding complexes and a few second pauses.A device interrogation was then performed with a programmer and noted the device had reverted to safety mode.There was concern that the device battery had depleted prematurely.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the device 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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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 that bradycardia therapy remained available.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 the patient implanted with this pacemaker was admitted to the hospital.Review of external monitoring equipment noted pacing spikes at a fixed rate of 72 paces per minute (ppm) with no corresponding complexes and a few second pauses.A device interrogation was then performed with a programmer and noted the device had reverted to safety mode.There was concern that the device battery had depleted prematurely.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the device 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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Search Alerts/Recalls
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