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 11/29/2023 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker reverted to safety mode.It was noted that the patient was not pacemaker dependent and has an underlying rate in the 40 beats per minute (bpm) range.Technical services (ts) reviewed safety mode parameters with the health care professional (hcp) and recommended device replacement.No further assistance was requested.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.
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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.The system resets occurred during other transient elevated power states 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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Event Description
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It was reported that this pacemaker reverted to safety mode.It was noted that the patient was not pacemaker dependent and has an underlying rate in the 40 beats per minute (bpm) range.Technical services (ts) reviewed safety mode parameters with the health care professional (hcp) and recommended device replacement.No further assistance was requested.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.Additional information was received from another manufacturer that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected.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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Event Description
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It was reported that this pacemaker reverted to safety mode.It was noted that the patient was not pacemaker dependent and has an underlying rate in the 40 beats per minute (bpm) range.Technical services (ts) reviewed safety mode parameters with the health care professional (hcp) and recommended device replacement.No further assistance was requested.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.Additional information was received from another manufacturer that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected.If the product is returned, analysis will be performed and this report would be updated at that time.
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Search Alerts/Recalls
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