Boston scientific received information that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device was explanted and will be returned for analysis.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to a product performance anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was included in the advisory population.
|
This device was thoroughly inspected and analyzed upon receipt at our quality assurance 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.
|