Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies; however holes were observed in both the ra and lv seal plugs.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The error code was determined to have been triggered due to the temperature decrease of the patients body post mortem, which resulted in the decrease of the battery voltage and resulting error code.
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