BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
|
Back to Search Results |
|
Model Number L311 |
Device Problems
Failure to Capture (1081); Pacing Problem (1439)
|
Patient Problems
Cardiac Arrest (1762); Loss of consciousness (2418); Convulsion/Seizure (4406); Syncope/Fainting (4411); Asystole (4442)
|
Event Date 09/17/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The product has been received for analysis.This report will be updated upon completion of analysis.
|
|
Event Description
|
It was reported that the patient was hospitalized after experiencing syncope with loss of consciousness and a seizure due to loss of capture and pacing inhibition with asystole.While in the emergency room (er), threshold testing was performed on both chambers.At the end of testing the right ventricular (rv) lead, loss of capture was observed and pacing did not resume for multiple seconds.Stat pacing was administered through the programmer and the device resumed pacing.Upon explanting and replacing the pacemaker, threshold testing was performed on the new pacemaker at 90 bpm and revealed normal function and good measurements.Further threshold testing was performed on the original rv lead at 120 bpm, and high thresholds were observed.The rv lead was explanted and replaced.Upon removal of the last suture on the rv lead, the lead sprung back; this suggested that lead dislodgement had occurred.No additional adverse patient effects were reported.The explanted pacemaker and rv lead have been received for analysis.
|
|
Event Description
|
It was reported that the patient was hospitalized after experiencing syncope with loss of consciousness and a seizure due to loss of capture and pacing inhibition with asystole.While in the emergency room (er), threshold testing was performed on both chambers.At the end of testing the right ventricular (rv) lead, loss of capture was observed and pacing did not resume for multiple seconds.Stat pacing was administered through the programmer and the device resumed pacing.Upon explanting and replacing the pacemaker, threshold testing was performed on the new pacemaker at 90 bpm and revealed normal function and good measurements.Further threshold testing was performed on the original rv lead at 120 bpm, and high thresholds were observed.The rv lead was explanted and replaced.Upon removal of the last suture on the rv lead, the lead sprung back; this suggested that lead dislodgement had occurred.No additional adverse patient effects were reported.The explanted pacemaker and rv lead have been received for analysis.
|
|
Manufacturer Narrative
|
The product has been received for analysis.This report will be updated upon completion of analysis.-- the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
|
|
Search Alerts/Recalls
|
|
|