On (b)(6) 2022 patient collapsed while working out, ems claimed patient was bradycardic and patient was taken to er where the physician determined that he was not receiving pacing.The pacing lead is a competitors lead.It is unclear whether this is a lead or device issue.Pacemaker was explanted.Should additional information become available, this file will be updated.
|
The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker 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 visually inspected revealing no anomalies.In particular the header of the device was analyzed.The set screw could be easily screwed in and out, there was no foreign material inside the header bore.All dimensions of the header bore were within the range requested by the is-1 standard specifications.Also the spring element of the pacemaker did not show any deviations.At a next step the pacemaker was interrogated and the pacemakers memory content was analyzed indicating no anomalies.The battery was found to be in eri status since (b)(6) 2022 after the explantation of the device.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.No intermittent or permanent loss of output was present.In summary, the device is fully functional.With regard to the issues as mentioned in the complaint description, the analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.
|