Sudden failure of implantable pulse generators: cause of failure and examination.

ABSTRACT

A sudden failure of implantable pulse generators used for spinal cord stimulation occurred in two patients. To identify the cause of this failure, an intensive destructive analysis of the explanted devices was carried out. A functional diagnosis was carried out by inspecting amplitude, pulse width and frequency on each output channel of the implantable pulse generators. Later, the titanium case of the pulse generators was opened by laser cutting to minimise any additional mechanical stress during the opening procedure. The functional test for both pulse generators showed faultless behaviour. Using light and electron microscopy, hairline cracks could be identified in the electrical connection between battery and electronic circuit. In both devices, the cracks spread through the whole bond wire in the connection to the plus pole of the battery and partially also to the minus pole. The analysis showed that both devices failed by broken bond wires. The electrical connection to the battery exists just by the spring characteristic of the wires. A push to the implant causes a short-term disconnection, resulting in a power on reset of the device. Manufacturing or design issues, allowing micromotion between battery and the hybrid part, may be the reason for this problem.