Model Number K187 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2023 |
Event Type
Injury
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Event Description
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It was reported that interrogation of this pacemaker with a programmer during a routine in clinic follow up noted that the device reverted to safety mode.The physician scheduled a device replacement procedure for a future date.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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Event Description
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It was reported that interrogation of this pacemaker with a programmer during a routine in clinic follow up noted that the device reverted to safety mode.The physician scheduled a device replacement procedure for a future date.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.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Event Description
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It was reported that interrogation of this pacemaker with a programmer during a routine in clinic follow up noted that the device reverted to safety mode.The physician scheduled a device replacement procedure for a future date.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.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.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 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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