It was reported that the surgeon was unable to tighten the set screw into the generator during an initial implant surgery.It was unknown if the set screw was stripped or if there was another issue.The surgeon eventually applied so much force that the polyethylene header assembly came off the generator can and fell on the floor.The surgeon and company representative were unable to find the set screw as it came out of the header, but it was confirmed that the screw did not fall into the patient.A different generator was then implanted.The device history record of the generator was reviewed, and the device conformed to all functional specifications prior to release.The generator was received, but analysis has not been approved to date.
|
Analysis on the generator was approved.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.Each of the returned torque wrenches secured a bench setscrew (each torque wrench made audible clicks) onto a bench lead and extracted the bench setscrew with no issues (lab conditions).In addition, review of the data downloaded from the pulse generator revealed diagnostics were performed, and an acceptable impedance value was obtained on the date of surgery.The setscrew and septum were not returned for evaluation.The header septum cavity met specification requirements.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.
|