The analysis accuracy and susceptibility to faults of the additional diagnostic functions were tested in 16 patients (eight men, eight woman, average age 61.5 +/- 10.8 years, 14 VVI, 2 AAI) with diagnostic pacemakers (Quintech DPG 921). The average observation period was 19.7 months. With 109 follow-up intervals of an average duration of 87 +/- 39 days, this meant an observation period of 25.9 patient years. A stage-by-stage test structure over several intervals of time was applied in order to validate the data acquired through pacemaker Holter functions by means of control ECGs and mathematical test methods. The only fault to occur in the diagnostic functions was a loss of stored data. This was observed in 10% of the follow-up intervals and was on the average 28% (16%-38%) of the total events. Forty-four percent (7/16) of the pacemakers were affected by this malfunction. Our results show that the diagnostic data are certainly correctly acquired. The clinical value of the diagnostic functions is clearly reduced by this potential loss of data.

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http://dx.doi.org/10.1111/j.1540-8159.1988.tb06300.xDOI Listing

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