This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting an is-1/df-1 lead into the header of this device resulting in sealing ring was damaged.Please refer to the description for more information regarding the specific circumstances of this event.
|
It was reported that during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d), the rv lead exhibited terminal end damage and the pin lead was difficult to insert into the header.The physician noted the proximal sealing ring was damaged and was able to remove it.Furthermore, the lead was fully inserted into the header without issues.Crt-d system remains in service.No additional adverse patient effects were reported.
|