BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
|
Back to Search Results |
|
Model Number G247 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
Device Overstimulation of Tissue (1991)
|
Event Date 12/04/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) heard beeping from the device and noted a thumping feeling.Upon interrogation, the device exhibited error codes and was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) heard beeping from the device and noted a thumping feeling.Upon interrogation, the device exhibited error codes and was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
|
|
Search Alerts/Recalls
|
|
|