Model Number V273 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Syncope/Fainting (4411); Asystole (4442)
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Event Date 10/06/2022 |
Event Type
Injury
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Event Description
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It was reported that the physician requested for a device check as this patient with a cardiac resynchronization therapy pacemaker (crt-p) exhibited syncopal episodes.This resulted in the patient experiencing asystole.Upon further investigation, it was found that this device is in safety mode.The patient was hospitalized overnight.The next day, the patient underwent a generator replacement, and the device was explanted and replaced successfully.The device is expected to be returned.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.
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Event Description
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It was reported that the physician requested for a device check as this patient with a cardiac resynchronization therapy pacemaker (crt-p) exhibited syncopal episodes.This resulted in the patient experiencing asystole.Upon further investigation, it was found that this device is in safety mode.The patient was hospitalized overnight.The next day, the patient underwent a generator replacement, and the device was explanted and replaced successfully.The device is expected to be returned.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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