Limitations of pacemaker system analyzers for the evaluation of implantable pulse generators.

A variety of commercial pacemaker system analyzers have been used to evaluate the electrical performance of pulse generators prior to implant or at the time of reoperation for pacemaker malfunction. We evaluated the ability of seven commercially available pacemaker system analyzers to provide the data required to determine if a given pulse generator was operating according to its manufacturer's specifications. While all pacemaker system analyzers provided accurate data for rate and pulse duration, values displayed for amplitude and sensitivity were inconsistent due to the methods each pacemaker system analyzer employed to measure these parameters. Overall, 22% of representative test sequences yielded data which would have resulted in the inappropriate rejection of the subject pulse generators for implantation. These observations suggest that pacemaker system analyzers are not suitable for evaluating all pulse generators. Moreover, physicians must be aware of these deficiencies in order to avoid the pitfalls of relying exclusively on pacemaker system analyzer data when troubleshooting pacemaker malfunction.