It was reported that through remote transmission, the device exhibited premature battery depletion.The physician noted that the device was not able to be interrogated and there was no pacing.The patient presented at the hospital, and the physician noted that the patient¿s heart failure was worsening.The device was explanted and replaced.Upon the device removal, the physician noted a round conformity on the device¿s surface.The patient was stable during and after the procedure.
|
No conclusion code available.Final analysis found the reported inability to communicate was confirmed in the laboratory and was due to premature battery depletion.Based on all available parameter and usage information, device longevity was found to be below the expected limits.With an external power supply attached, the device functioned normally.No high current was detected during testing and the power consumption was normal.The original battery was returned to the vendor for further evaluation and analysis could not conclusively determine a root cause for the premature battery depletion.
|
Premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.In further analysis of the battery, lithium clusters were observed, but at the time of analysis the clusters did not appear to be in a location or size that would be sufficient to cause an internal short of the battery.As a result, the cause of the premature battery depletion could not be conclusively determined.However, from these analyses, in the absence of other root causes, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.
|