It was reported that the patient presented for a scheduled procedure.During the procedure, the physician was trying to insert the hex wrench into the left ventricular lead port however, the set screw would not engage.A new wrench was attempted and still unable to unscrew.The device was removed and replaced.There were no patient consequences.
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The reported field event of lead connection issue was confirmed.The device was above elective replacement indicator (eri) when received.Analysis revealed the rv (df4) set screw was backed out from its thread as a result of unscrewing the set screw too far and it contained septum material inside the cavity.When the screw was re-engaged with the connector block, the screw operated normally in affixing the test lead to the header.The connection anomaly was consistent with having occurred during the procedure.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.
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