Model Number G125 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) entered in safety mode.Additionally, it experienced difficulty to be interrogated since the device was in safety mode.This device was explanted and replaced.This device is expected to be returned for analysis.No further 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) entered in safety mode.Additionally, it experienced difficulty to be interrogated since the device was in safety mode.This device was explanted and replaced.This device is expected to be returned for analysis.No further 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.
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Search Alerts/Recalls
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