The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply. Model 1850, 1852, 1855 and 1856, no serial numbers will be retrieved. Model 1851, serial number: 301173 Model 1853, serial number: 405161 Model 1857, serial numbers: 701901, 705521, 705555, 705564, 705568, 705575, 705624, 705721, 705759, 705774. Model 1858, serial numbers: 801463, 801487, 801489, 801505, 801511, 801512, 801517, Model 1860, serial number 131043 Model 1861, serial numbers 201166, 230949
nationwide within US only (OUS distribution not affected).
Description du dispositif
VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA