Analysis was performed on the returned generator and showed that the pulse generator performed according to functional specifications.
Detachment of the septum plug was observed ¿as received¿ prior to decontamination, which may possibly be implant-related damage.
The returned setscrew shows mechanical wear on the socket (suggesting numerous insertion attempts) and septum debris is in the socket (verifies the setscrew was extracted up into the septum).
In addition, the returned septum shows damage on the underneath side, which indicates the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the septum plug.
The header septum cavity and returned septum meets specification requirements.
Other than the noted septum plug detachment, there were no performance or any other type of adverse conditions found with the pulse generator.
|