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Safety Information

Published: 17 May 2012

St Jude Medical Riata Implantable Defibrillator Leads

17 May 2012

Medsafe is providing the following information to the public about Riata and Riata ST implantable defibrillator leads manufactured by St Jude Medical Inc., USA.

Issue

St Jude Medical Inc. has determined that approximately 0.63% of Riata and Riata ST implantable defibrillator leads are experiencing outer insulation failure. Of those leads that experience outer insulation failure a proportion (approximately one sixth) result in the conductors becoming exposed (externalised). Should either of these situations occur the lead may develop an electrical problem and not function as intended. This may impact on the ability of the implantable defibrillator the leads are connected to, to not pace or defibrillate as required.

This issue only relates to the models of leads detailed below.
Riata Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042.

Action

St Jude Medical have issued a letter to surgeons and cardiac technicians to inform them of this alert and to advise them to contact all patients who have Riata and Riata ST defibrillator leads implanted.

Medsafe has been advised that 167 Riata leads have been supplied in New Zealand.

The Riata leads were withdrawn from sale in December 2010.

In line with international guidelines for patients who have these leads implanted it is recommended that patients should be followed up on a three (3) monthly basis.

Information from the manufacturer

External link to the St Jude Medical website for information on this matter.

Links to more information

External link to UK Medicines and Healthcare products Regulatory Authority (MHRA) notice concerning Riata defibrillator leads (Acrobat PDF document, 878kB)

External link to US Food and Drug Administration (FDA) notice concerning Riata defibrillator leads

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