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Model Number V183 |
Device Problems
Premature Discharge of Battery (1057); Pacing Problem (1439); Inappropriate or Unexpected Reset (2959)
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Patient Problems
Fall (1848); Syncope/Fainting (4411)
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Event Date 02/08/2023 |
Event Type
Injury
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Event Description
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It was reported that during a routine in-clinic follow-up, this cardiac resynchronization therapy pacemaker (crt-p) was found to have reverted to safety mode.The patient was pacemaker dependent.It was noted that the device showed a battery status of 10 to 11 months remaining during the previous in-clinic follow-up approximately 6 months ago.The physician scheduled the patient for a device replacement procedure on a future date and the patient left the clinic.While walking to their car, the patient experienced a syncopal episode and collapsed.The patient was taken to the hospital and placed on a cardiac monitor.Review of monitoring data showed pacing inhibition with left arm movement.It was noted that the device was implanted in the left pectoral area.The patient was taken to the cardiac catheterization laboratory where a temporary pacing wire was placed.This device was then explanted and replaced.The patient remained in the hospital for 2 days and was then discharged.No additional adverse patient effects were reported.The return of this 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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Event Description
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It was reported that during a routine in-clinic follow-up, this cardiac resynchronization therapy pacemaker (crt-p) was found to have reverted to safety mode.The patient was pacemaker dependent.It was noted that the device showed a battery status of 10 to 11 months remaining during the previous in-clinic follow-up approximately 6 months ago.The physician scheduled the patient for a device replacement procedure on a future date and the patient left the clinic.While walking to their car, the patient experienced a syncopal episode and collapsed.The patient was taken to the hospital and placed on a cardiac monitor.Review of monitoring data showed pacing inhibition with left arm movement.It was noted that the device was implanted in the left pectoral area.The patient was taken to the cardiac catheterization laboratory where a temporary pacing wire was placed.This device was then explanted and replaced.The patient remained in the hospital for 2 days and was then discharged.No additional adverse patient effects were reported.The return of this 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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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 due to system resets.It was confirmed that brady 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 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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Search Alerts/Recalls
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