A study was undertaken to determine the most effective method of pacemaker follow-up in terms of the total number of complications detected and yield per follow-up in single and dual chamber pacing systems. The analysis involved 9,786 patient records from 635 patients. The records were reviewed with respect to method of follow-up, number of chambers paced, and complications detected. Complications included: oversensing, undersensing, noncapture, pocket and diaphragmatic stimulation, pacemaker mediated tachycardia, crosstalk, pulse generator malfunction, lead malfunction, infection/erosion, premature end of service, exit block, and other miscellaneous problems. Eight thousand two hundred eighty-eight of the 9,786 follow-ups were performed in the office while 1,498 were transtelephonic. Single chamber pacing systems were implanted in 329 patients and 306 were dual chamber systems. A total of 599 complications were detected. Analysis yielded a per patient complication rate of 5.1% (single chamber) and 8.4% (dual chamber) for in-office follow-up. This compared to a transtelephonic follow-up per patient complication rate of only 0.3% (single chamber) and 1.0% (dual chamber). In-office pacemaker follow-up is significantly more effective (P < 0.001) than transtelephonic follow-up in detecting both single and dual chamber pacemaker system complications.
A case of unintentional misprogramming is described in which a DDDR pacemaker, programmed to the VVIR mode, reverted to the originally programmed parameters and mode. The misprogramming requires that a particular sequence of steps be followed and has been verified by the manufacturer. This misprogramming may be clinically significant and can be reproduced in an entire family of current pacemakers based on the same software platform.
A 75-year-old male was implanted with a Telectronics Meta DDDR model 1250 pacemaker 47 months ago. The patient was evaluated in-office for symptomatic complaints of dizziness, palpitations, and "too slow or too fast" pulse rates. Upon examination, the device displayed sudden no output manifestations for which the device had been recalled. However, the device further displayed erratic paced rates to 200 ppm, switching between VVIR and DDDR modes. To the best of our knowledge, this is a previously unreported manifestation in this recalled device and needs to be addressed due to its potentially hazardous patient effects.
A bench study was performed on 42 different pulse generators (PGs) to evaluate the time required to actuate and "emergency backup" (EBU) program. PGs were programmed to loss of capture before the EBU programming key was activated. Activation times for the EBU pause were measured on an ECG strip from the first noncaptured beat to the first recaptured beat while the total pause was measured between the two captured beats. Each test was performed five times. Special features for temporary threshold testing were also evaluated. Mean activation times for EBU pauses ranged from 1.46-11.90 seconds with total pauses of 2.18-12.94 seconds. Significant differences were observed for EBU activation times from the same PG but utilizing older and newer generation programmers, e.g., 10.90 (old) versus 4.54 seconds (new) for a mean EBU pause. Extreme variations existed in EBU activation times for programmers with multiple "EBU keys" for the same PG, e.g., 12.94 versus 4.96 seconds for the mean total pause. The special features for temporary threshold testing resulted in mean EBU pauses measuring 0.62-2.88 seconds and mean total pauses of 1.21-3.76 seconds. The special features were significantly faster than manual activation of the "EBU key" for regaining capture with few exceptions. Activation times were complicated by multiple programmers for the same PG and several "EBU keys" on the same programmer.
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