Model Number ACCESSORY |
Device Problem
Human-Device Interface Problem (2949)
|
Patient Problem
Cardiac Tamponade (2226)
|
Event Date 02/18/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
|
|
Event Description
|
Boston scientific received information that this patient with an cardiac resynchronization therapy pacemaker (crt-p) device had perforation and tamponade during implant.Moreover, the patient had history of atrial fibrillation (af).The device remains in service.No additional adverse patient effects were reported.
|
|
Event Description
|
Boston scientific received information that during implant procedure for this cardiac resynchronization therapy pacemaker (crt-p) device, when canulating the coronary sinus to implant another manufacturer's left ventricular (lv) lead, a perforation and tamponade occurred.Additional information was received that there was a pericardial effusion and the pericardium was successfully drained during the procedure.At this time there is no evidence to support that the crt-p contributed to the perforation and both the crt-p and another manufacturer's lv lead remain in service.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|