Boston scientific received information that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) presented for a procedure to implant a left ventricular (lv) lead after an unsuccessful attempt at initial system implant.Upon opening the device pocket the right atrial (ra) and rv leads were found under tension, but not dislodged, due to loose suture sleeves.The physician elected to disconnect the leads from the device and advance the lead bodies to the appropriate position using a stylet.The rv setscrew was loosened and observed to remain on the torque wrench upon its removal.The physician attempted to replace the setscrew but the rv header seal ring became deformed.The physician released the ra lead without issue using the same wrench and replaced the device.A lv lead was then implanted without issue.No adverse patient effects were reported.
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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted damage to the rv seal plug.The device was then exposed to simulated heart load conditions, and the defibrillation, 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 confirmed the reported clinical observations as the result of damage induced during the explant procedure.
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