FDAnews Device Daily Bulletin

Stubborn Lead Leads to Safety Notice

Feb. 29, 2012
Sorin CRM received reports in post-market studies that part or all of the fixation helix of the SonRtip endocardial pacing lead with contractility sensor, model No. PS55D, remained in the myocardium after the lead had been removed, leading to a field safety notice from the Medicines and Healthcare products Regulatory Agency.