Setrox S Active Fixation Leads - BIOTRONIK USA - News

More documents

Recommendations

Info

10 Setrox S Steroid-Eluting Leads Technical ManualCross-Threading SetscrewTo prevent cross-threading the setscrew, do not back the setscrewcompletely out of the threaded hole. Leave the torque wrench in the slotof the setscrew while the lead is inserted.Tightening SetscrewDo not over-tighten the setscrew(s). Use only a torque wrench, whichautomatically prevents over-tightening.Sealing CapsFor pacemakers requiring sealing caps, secure a sealing cap over thesetscrew(s) to prevent pacemaker malfunction.
5. Potential Adverse EventsSetrox S Steroid-Eluting Leads Technical Manual 11Potential complications resulting from the use of endocardial leadsinclude, but are not limited to: thrombosis, embolism, body rejectionphenomena, cardiac tamponade, pneumothorax, muscle/nervestimulation, valve damage, fibrillation, infection, skin erosion andventricular ectopy. Lead perforation through the myocardium has beenrarely observed. The table below summarizes some of the potentialsymptoms indicating a complication and possible corrective actions:Table 1: Potential Complications and Corrective ActionsSymptomLoss ofpacing orsensingIncrease/decrease inthresholdPotential ComplicationLead dislodgementLead fractureSetscrew penetrationof lead insulationImproper lead / pulsegenerator connectionFibrotic tissueformationPotential CorrectiveActionReposition leadReplace leadReplace leadReconnect lead topulse generatorAdjust pulsegenerator output;Replace/repositionlead
Page 1 and 2: BIOTRONIKSetrox S LeadsTechnical Ma
Page 3 and 4: ContentsSetrox S Steroid-Eluting Le
Page 5: 1. Device DescriptionSetrox S Stero
Page 8 and 9: 4 Setrox S Steroid-Eluting Leads Te
Page 16 and 17: 12 Setrox S Steroid-Eluting Leads T
Page 36: 32 Setrox S Steroid-Eluting Leads T

Setrox S Active Fixation Leads - BIOTRONIK USA - News

Create successful ePaper yourself

Delete template?

Save as template?