Simplifying Global Compliance
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.
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