Model Number G151 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Electric Shock (2554); Asystole (4442)
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Event Date 05/19/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode.Additionally, there was noise that was being oversensed resulting in pacing inhibition and ten inappropriate shocks.The patient did experience asystole of greater than two seconds.Subsequently, this device was explanted and replaced successfully.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Correction to fields h6 patient codes and impact codes.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode.Additionally, there was noise that was being oversensed resulting in pacing inhibition and ten inappropriate shocks.The patient did experience asystole of greater than two seconds.Subsequently, this device was explanted and replaced successfully.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode.Additionally, there was noise that was being oversensed resulting in pacing inhibition and ten inappropriate shocks.The patient did experience asystole of greater than two seconds.Subsequently, this device was explanted and replaced successfully.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 and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.Correction to fields h6 patient codes and impact codes.
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Search Alerts/Recalls
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