During follow-up, an impedance of above 3000 ohms was noted on all channels.Suspicion of lead breakage.During the revision surgery, it was also noticed that all poles of the lv lead were dislodged into the atrium.Lead was explanted.Should additional information be received, this file will be updated.
|
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.In the course of the analysis, no deviations were noted, which can be considered to be the root cause of the clinical observation.The lead proved to be without fault throughout its inspection.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
|