NRAC Issue #1577 ADDENDUM				May 10, 2006   		 

PRODUCT       a) Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3
              HE (models H177, H179) Cardiac Resynchronization Therapy
              Defibrillator (CRT-D). Sterile EO.  Cardiac resynchronization
              therapy defibrillators (CRT-D) provide ventricular
              tachyarrhythmia and cardiac resynchronization therapies.
              Ventricular tachyarrhythmia therapy is for the treatment of
              ventricular tachycardia (VT) and ventricular fibrillation (VF),
              rhythms that are associated with sudden cardiac death
              (SCD). Cardiac resynchronization therapy is for the treatment of
              heart failure (HF) and uses biventricular electrical stimulation
              to synchronize ventricular contractions.
              Cardioversion/defibrillation therapies include a range of
              low-and high-energy shocks using either a biphasic or monophasic
              waveform
RECALL NUMBER # Z-0825-06;
PRODUCT       b) Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL
              4 HE (model H197).  Cardiac Resynchronization Therapy
              Defibrillator (CRT-D). Sterile EO. Cardiac resynchronization
              therapy defibrillators (CRT-D) provide ventricular
              tachyarrhythmia and cardiac resynchronization therapies.
              Ventricular tachyarrhythmia therapy is for the treatment of
              ventricular tachycardia (VT) and ventricular fibrillation
              (VF), rhythms that are associated with sudden cardiac death
              (SCD). Cardiac resynchronization therapy is for the treatment of
              heart failure (HF) and uses biventricular electrical stimulation
              to synchronize ventricular contractions.
              Cardioversion/defibrillation therapies include a range of
              low-and high-energy shocks using either a biphasic or monophasic
              waveform,
RECALL NUMBER # Z-0826-06;
PRODUCT       c) Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac
              Resynchronization Therapy Defibrillator (CRT-D). Sterile EO.
              Cardiac resynchronization therapy defibrillators (CRT-D) provide
              both atrial and ventricular tachyarrhythmia and cardiac
              resynchronization therapies. Ventricular tachyarrhythmia therapy
              is for the treatment of ventricular tachycardia (VT) and
              ventricular fibrillation (VF), rhythms that are associated with
              sudden cardiac death (SCD). Atrial tachyarrhythmia therapy is
              for the treatment of supraventricular tachycardia (SVT) and
              atrial fibrillation (AF). Cardiac resynchronization therapy is
              for the treatment of heart failure (HF) and uses biventricular
              electrical stimulation to synchronize ventricular contractions.
              This device also uses accelerometer-based adaptive-rate
              bradycardia therapy. Cardioversion/defibrillation therapies
              include a range of low-and high-energy shocks using either a
              biphasic or monophasic waveform,
RECALL NUMBER # Z-0827-06;
PRODUCT       d) Guidant VITALITY HE Implantable Cardioverter Defibrillator
              (model T180). Sterile EO.  This ICD is 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 device
              offers dual-chamber bradycardia features (atrial and/or
              ventricular pacing and sensing),
RECALL NUMBER # Z-0828-06
CODE          a) Model H170, serial numbers: 364406, 364446, 364542, 364576,
              364582, 364586, 364587, 364590, 364591, 364593, 364595, 364596,
              364597, 364599, 364600, 364601, 364602, 364604, 364605, 364606,
              364607, 364608, 364609, 364611, 364613, 364615, 364623, 364625,
              364632, 364633, 364634, 364636, 364643, 364680, 364732, 364735,
              364752. Model H175, serial numbers: 315437, 315438, 315452,
              315454, 315455, 315456, 315461, 315462, 315464, 315470, 315473,
              315480, 315482, 315489, 315496, 315497, 315500, 315580, 315588,
              315605. Model H177, serial number: 285055
              Model H179 serial numbers: 114267, 114268, 114269, 114270,
              114271, 114280, 114470;
              b) Model H190, serial numbers: 311739, 311740, 311742, 311743,
              311744, 311745, 311747, 311748, 311751, 311769, 311811, 311834,
              311850, 311852, 311853, 311884, 311895, 311900,
              Model H195 serial number: 353166.
              Model H197, serial number: 310331;
              c) Serial numbers: 200099, 200103, 200104;
              d) Serial numbers: 204707, 204711, 204751, 204754, 204908
MANUFACTURER  Guidant-Ireland, Clomel, Ireland,
RECALLED BY   Guidant Corporation, Saint Paul, MN,
QUANTITY      77 devices
DISTRIBUTION  Nationwide and Internationally
REASON        77 distributed devices may have a cracked layer of insulation in
              a flexible hybrid circuit, leading to internal shorting during
              charging such as during routine capacitor formation or for
              defibrillation. This would likely render the device
              non-functional, resulting in no output and/or telemetry
              communications.

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