Safety Notice for ISOLINE defibrillation leads, Sorin Group Italia Srl
2013.02.05
Product group Active implantable medical devices - defibrillators
Reference 00433/13
Sorin Group Italia Srl has issued an urgent Field Safety Notice of implantable bipolar defibrillation leads ISOLINE, models 2CR5, 2CR6 and 2CT6. The information is regarding the potential for internal insulation breach resulting in low pacing impedance, and/or ventricular oversensing and /or inappropriate therapies.