Model Number V173 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
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Patient Problem
Asystole (4442)
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Event Date 01/09/2024 |
Event Type
Injury
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Event Description
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It was reported that, during the pre-check of a normal battery depletion procedure.This implantable pacemaker was attempted to be interrogated, however, once held the wand over the device, the device exhibited pacing inhibition.It was suspected that the device entered in safety mode.Since the procedure was already scheduled the device was explanted and replaced.No further adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was added to the following fields: b5: describe event or problem field.H6: device codes.
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Event Description
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It was reported that, during the pre-check of a normal battery depletion procedure.This implantable pacemaker was attempted to be interrogated, however, once held the wand over the device, the device exhibited pacing inhibition.It was suspected that the device entered in safety mode.Since the procedure was already scheduled the device was explanted and replaced.No further adverse patient effects were reported.Additional information was received detailing that the device did not enter in safety mode.Additionally, the pacing inhibition was observed for four minutes.This device is expected to be returned 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.Additional information was added to the following fields: b5: describe event or problem field, h6: device codes.
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Event Description
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It was reported that, during the pre-check of a normal battery depletion procedure.This implantable pacemaker was attempted to be interrogated, however, once held the wand over the device, the device exhibited pacing inhibition.It was suspected that the device entered in safety mode.Since the procedure was already scheduled the device was explanted and replaced.No further adverse patient effects were reported.Additional information was received detailing that the device did not enter in safety mode.Additionally, the pacing inhibition was observed for four minutes.This device is expected to be returned for analysis.
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Search Alerts/Recalls
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