Model Number G154 |
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 10/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had entered safety mode and had required three resets to obtain this status.This device was not implanted; no patient involvement reported.
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Manufacturer Narrative
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Correction: b5 updated for clarity.Upon receipt at our post market quality assurance laboratory, the device was confirmed to be operating in safety mode as was reported from the field.Memory review confirmed that the device underwent a reset due to memory corruption.A memory error was recorded on september 15, 2020 followed by three device faults.It is normal device function for this product to revert to safety mode after detecting three faults in a short period of time.The device reverted to a safety mode with limited programmability, in which single chamber pacing and defibrillation therapy were available.Detailed analysis determined the root cause of the memory corruption appeared to be due to an issue with a digital integrated circuit component.The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that upon device interrogation prior to implant, this cardiac resynchronization therapy defibrillator (crt-d) had entered safety mode.This device was not implanted and was returned for analysis.
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Search Alerts/Recalls
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