Model Number V173 |
Device Problem
Defective Device (2588)
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Patient Problem
Syncope/Fainting (4411)
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Event Date 06/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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This investigation will be updated should further pertinent information be provided.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) suffered a syncope after was described as an electric shock while trying to place a communicator at a better location as several yellow collecting waves appeared.The device remains in service at this moment.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Corection of b2 field: outcomes attrib to adv event.This investigation will be updated should further pertinent information be provided.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) suffered a syncope after was described as an electric shock while trying to place a communicator at a better location as several yellow collecting waves appeared.The device has been explanted due to normal battery depletion and has been returned for analysis without any additional allegation.No additional adverse patient effects were reported.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) suffered a syncope after was described as an electric shock while trying to place a communicator at a better location as several yellow collecting waves appeared.The device has been explanted due to normal battery depletion and has been returned for analysis without any additional allegation.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 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.Correction of b2 field: outcomes attrib to adv event.This investigation will be updated should further pertinent information be provided.
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Search Alerts/Recalls
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