Model Number 0672 |
Device Problems
Failure to Capture (1081); High Capture Threshold (3266)
|
Patient Problems
Cardiac Arrest (1762); Cardiac Perforation (2513)
|
Event Date 03/02/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that this patient experienced cardiac arrest while on vacation in late january.Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.
|
|
Event Description
|
It was reported that this patient experienced cardiac arrest while on vacation in late january.Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.
|
|
Manufacturer Narrative
|
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a malfunction; please refer to the description b5 field for more information regarding the specific circumstances of this event.
|
|
Event Description
|
It was reported that this patient experienced cardiac arrest while on vacation in late (b)(6).Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.
|
|
Manufacturer Narrative
|
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.The related investigation determined that this lead was associated with a reported perforation and laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.Please refer to the description for more information regarding the specific circumstances of this event.
|
|
Search Alerts/Recalls
|