Device typeImplantable pacemaker analyser, intraoperative: An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.
FDA categoryANALYZER, PACEMAKER GENERATOR FUNCTION, TESTER, PACEMAKER ELECTRODE FUNCTION
Device ID00643169957657
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information