BEUDAMED
    92 results · 82ms · Sources: EU EUDAMED, US FDA

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    TELIGEN

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CRM CORP·Product code LWP·June 14, 2021

    BOSTON SCIENTIFIC PACEMAKER

    FDA Adverse Event
    BOSTON SCIENTIFIC CRM CORP·Product code LWP·October 14, 2020

    LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·April 10, 2013

    INSIGNIA ULTRA

    FDA Adverse Event
    Death ·CLONMEL·Product code DXY·September 28, 2007

    VENTAK PRIZM 2 DR

    FDA Adverse Event
    Death ·Product code LWS·September 14, 2007

    CONTAK RENEWAL

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·September 14, 2007

    CONTAK RENEWAL

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·September 14, 2007

    VENTAK PRIZM 2 DR

    FDA Adverse Event
    Death ·Product code LWS·September 14, 2007

    CONTAK RENEWAL

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·September 14, 2007

    CONTAK RENEWAL

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·September 14, 2007

    VENTAK PRIZM 2 DR

    FDA Adverse Event
    Death ·Product code LWS·September 14, 2007

    VENTAK PRIZM 2 DR

    FDA Adverse Event
    Death ·Product code LWS·September 14, 2007

    VENTAK PRIZM 2 DR

    FDA Adverse Event
    Death ·Product code LWS·September 14, 2007

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·May 29, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·August 28, 2013

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013