After an implantation period of approx.79 months, an intermittent loss of capture, high rv threshold and undersensing were observed.The pacemaker was explanted.No adverse patient events were reported.Should additional information be received, this file will be updated.
|
The device was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was properly interrogated, and the memory content was analyzed indicating no anomalies.The battery status was found to be greater than 35 percent.Capture control was not activated.In addition, follow-up data from (b)(6) 2023, documented a ventricular pacing output of 5.4 v at 1.0 ms.During that follow-up ventricular threshold measurements revealed thresholds of 1.6 v / 1.0 ms unipolar and 2.0 v / 1.0 ms bipolar.Ineffective stimulation could not be confirmed based on these data.The previous follow-up was on (b)(6) 2023.It is assumed that the ineffective stimulation occurred already on that day and the ventricular output was then programmed to 5.4 v.However, for further insights these data would be essential.The header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.Also, the spring elements of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.There was no intermittent or permanent loss of output.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.
|