Model Number V173 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient presented to the emergency room and it was not possible to interrogate the device.The cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.It was unknown if the patient had undergone radiation or other therapy that could have triggered the safety mode.The crt-p was successfully explanted and replaced.No additional adverse patient effects were reported.
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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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Event Description
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It was reported that the patient presented to the emergency room and it was not possible to interrogate the device.The cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.It was unknown if the patient had undergone radiation or other therapy that could have triggered the safety mode.The crt-p was successfully explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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