BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number K187 |
Device Problems
Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 03/28/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient presented for a routine in-clinic follow-up with complaint of experiencing twitching in the device pocket at the incision site.It was noted that the device was programmed to high outputs due to both implanted leads being epicardial.An initial attempt to interrogate the device with a programmer was unsuccessful, however, a subsequent attempt was successful.Review of interrogation data noted that the device had recorded codes and reverted to safety mode.The patient was not pacemaker dependent.A device replacement procedure was scheduled for the following day and the patient was sent home.Additional information was then received that surgical intervention was undertaken as planned the following day.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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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 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 presented for a routine in-clinic follow-up with complaint of experiencing twitching in the device pocket at the incision site.It was noted that the device was programmed to high outputs due to both implanted leads being epicardial.An initial attempt to interrogate the device with a programmer was unsuccessful, however, a subsequent attempt was successful.Review of interrogation data noted that the device had recorded codes and reverted to safety mode.The patient was not pacemaker dependent.A device replacement procedure was scheduled for the following day and the patient was sent home.Additional information was then received that surgical intervention was undertaken as planned the following day.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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Search Alerts/Recalls
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