It was reported that this subcutaneous implantable cardioverter-defibrillator (s-icd) was being removed for normal battery depletion.During the procedure, the electrode was found to be stuck in the header.The hex wrench turned the set screw and pulled on the electrode to remove it from the header, the screw was released successfully.The electrode measurements were ok and thus, the electrode was used with the new device.There was no harm reported to the patient.
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Boston scientific determined the most probable cause of the event was related to an unintended user error.The s-icd instructions for use (ifu) cautions users against using a non-boston scientific torque wrench and over-ratcheting the wrench when loosening setscrews on our devices which could result in them becoming stuck.The ifu provides additional instructions on how to loosen stuck setscrews if they occur during procedures.However, boston scientific is currently investigating these cases of difficulty loosening stuck setscrews to determine what other factors may contribute to these events.
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