Boston Scientific (formerly Guidant) has advised the MHRA of a series of problems affecting some of its implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT Ds) and pacemakers and has issued information to UK clinicians about clinical follow-up of affected patients.
Following discussion with Boston Scientific/Guidant, the MHRA has communicated information about some of these problems to hospitals in England via the Medical Device Alerts (MDA) listed below. Where the company has issued a communication to UK hospitals and where the MHRA has not issued corresponding advice, the company’s communication is listed below and has been placed in the ‘Field Safety Notices for medical devices’ section of the MHRA website. The MHRA has also informed the devolved administrations in Scotland, Wales and Northern Ireland about these issues.
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Medical Device Alert Reference
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Medical Device Alert Action Status
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Medical Device Alert Title/
Manufacturer Field Safety Notification |
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| Boston Scientific Field Safety Notification (FSN) - 15 January 2008 regarding models subject to a certain failure mechanism if implanted in a susceptible orientation. This is an extension of an earlier advisory, distributed in May 2006. | ||
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Guidant Field Safety Notification (FSN) - 11 April 2007: ‘Potential for reduced ERI to EOL time due to low voltage degradation in a subset of CONTAK RENEWAL® 4, VITALITY and VITALITY 2 ICDs and CRT-Ds’ |
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| MDA/2007/023 | Action | Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families |
| MDA/2006/038 | Immediate action Information request |
Guidant implantable pacemaker and implantable defibrillator families: INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 Guidant Field Safety Notification (FSN) - 8 September 2006: |
| MDA/2006/006 | Immediate action Update |
Guidant implantable pacemaker models: PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN®, CONTAK® TR |
| MDA/2005/070 | Immediate action Update |
Guidant INSIGNIA and NEXUS implantable pacemakers (This alert is an update to MDA/2005/067) |
| MDA/2005/067 | Action | Guidant INSIGNIA and NEXUS implantable pacemakers |
| MDA/2005/048 |
Immediate action, update Supersedes MDA/2005/039 |
Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - specific AVT models: VENTAK PRIZM AVT® model 1900, VITALITY® AVT models A135 and A155, CONTAK RENEWAL® 4 AVT models M170 and M175, CONTAK RENEWAL® 4 AVT HE models M177 and M179 |
| MDA/2005/047 | Immediate action | Guidant implantable pacemaker models: PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN®, CONTAK® TR, Manufactured between 25 November 1997 and 26 October 2000 |
| MDA/2005/041 | Immediate action | Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) |
| MDA/2005/039 | Withdrawn | Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - specific AVT models: VENTAK PRIZM AVT® model 1900, VITALITY® AVT models A135 and A155, CONTAK RENEWAL® 4 AVT models M170 and M175, CONTAK RENEWAL® 4 AVT HE models M177 and M179 |
| MDA/2005/038 | Action | Guidant CONTAK RENEWAL®, (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds) |
| MDA/2005/037 | Action | Guidant VENTAK PRIZM® 2DR implantable cardioverter defibrillator (ICD) model No 1861 |
The MHRA, which is taking the lead on these issues within the UK, monitors and evaluates associated incident reports received from UK clinicians, via the MHRA adverse incident reporting system.
Patients who think they may have any of the affected devices are advised to contact their pacemaker/ICD follow-up centre if they have questions or concerns.
