Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
Boston Scientific has released the Brady SMR6 correction for ACCOLADE pacemakers and CRT-Ps, expanding the scope of the correction to include CRT-P and DR-EL devices.
Boston Scientific, clinical personnel managing patients with ACCOLADE/CRT-P/DR-EL devices, and quality/regulatory departments responsible for device corrections.
The expansion of the correction to include additional device models (CRT-P and DR-EL) suggests that the underlying issue originally identified in the ACCOLADE line may be present across a broader technical platform. Regulatory teams should anticipate increased scrutiny on the effectiveness of this software or hardware correction, as the availability of Brady SMR6 implies a specific remedial action is now required for a larger patient population.
Regulatory and quality teams should verify if the Brady SMR6 update is applicable to their specific ACCOLADE, CRT-P, or DR-EL inventory. Clinical and post-market teams must ensure that correction procedures are followed for the expanded device list to maintain compliance with safety reporting requirements.
Brady SMR6 is now available for ACCOLADE pacemakers and CRT-Ps; correction expanded to include CRT-P and DR-EL devices.
Open in openFDA / FDA.gov