Model Number G247 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was interrogated prior to implant and was found to be operating in safety mode.The device was therefore not implanted.There was no patient involvement.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was interrogated prior to implant and was found to be operating in safety mode.The device was therefore not implanted.There was no patient involvement.
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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.This product has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.
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Search Alerts/Recalls
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