Boston Scientific has issued a letter notifying affected clients that sure Endotak Reliance Defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils might influence shock efficacy and/or require early substitute, in keeping with an FDA alert.
In accordance with the FDA, the most typical hurt is early lead substitute, and probably the most critical hurt is loss of life or want for cardiac resuscitation because of non-conversion of a sustained ventricular arrhythmia from a diminished shock vitality because of excessive impedance.
Per the FDA alert, Boston Scientific has reported 386 critical accidents and 16 affected person deaths related to this situation, as of July 24.
Boston Scientific Endotak Reliance leads are meant for pacing, rate-sensing, and supply of cardioversion and defibrillation shocks when used with a suitable pulse generator, the FDA says.
The FDA says findings of a Boston Scientific investigation the gadgets embody:
- Whereas cracking of calcified ePTFE coating has been noticed, calcification of the shock coil(s) doesn’t compromise the bodily or electrical integrity of the lead.
- A development of progressively rising LVSI is correlated with shock coil calcification and is extra prevalent with BSC RELIANCE ePTFE defibrillation leads in comparison with non-ePTFE defibrillation leads from BSC and different producers; leads could also be implanted for eight or extra years previous to manifestation of this development.
- The shock coil encapsulant materials might exhibit a polarity bias with Reversed (RV+) polarity having an elevated excessive voltage shock impedance (HVSI) relative to Preliminary (RV-) polarity7. Reversed (RV+) polarity shocks are 4.5 instances extra prone to provoke a excessive, delivered shock impedance alert (Code-1005), and defibrillation programs programmed to Reversed (RV+) polarity exhibiting a gradual rising LVSI have a decrease defibrillator-determined shock success charge.
- When managing leads with calcified coil(s), supply of commanded shocks is neither efficient at completely mitigating rising impedance danger nor predictive of future impedance as LVSI might initially lower however usually returns to pre-shock values in lower than six months.
For a full listing of affected gadgets, see the FDA web site.
