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The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.