This device was thoroughly inspected and analyzed upon receipt at our (b)(4) laboratory.Review of the device memory indicated that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.A series of automated electrical/functional tests were conducted and no issues with device performance were observed; basic sensing, pacing and shocking functions of the device were verified.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device's battery.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.Analysis of the memory indicates that the fc1003 was induced by exposure to cold temperature below labeling (0°c) while in the shipping box.
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