News | Leads Implantable Devices | January 25, 2016

FDA Issues Serious Warning on St. Jude Optisure High-voltage Leads

Agency upgrades voluntary global field safety action to Class 1 recall for implantable cardioverter defibrillator leads that may exhibit electrical malfunction due to variation in manufacturing process

St. Jude Medical, Optisure leads, FDA Class 1 Advisory, ICDs

January 26, 2016 — St. Jude Medical Inc. is recalling the Optisure implantable cardioverter defibrillator (ICD) leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient. The U.S. Food and Drug Administration (FDA) said use of affected products may cause serious adverse health consequences, including patient injury or death. 

Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators (ICDs), which monitor the heartbeat of patients suffering from heart rhythm disorders. An ICD’s leads deliver electric current to the heart to help restore the heart to its normal rhythm when needed.

Last week,  St. Jude announced that a previously communicated voluntary global field safety action related to the company’s Optisure Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the FDA. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the United States, which may have been damaged during a manufacturing step. The company has received no reports of lead malfunction or patient injury related to this issue and all physicians with patients impacted by this advisory have been notified. The advisory was updated to a full Class 1 Recall Jan. 26.

On Nov. 3, 2015, St. Jude Medical began the global process of notifying physicians following patients who have been implanted with the 447 Optisure dual coil leads subject to this advisory. An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava (SVC) shock coil in a limited and well-defined group of Optisure leads could result in cuts to the insulation of the lead. Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high-voltage therapy.

A St. Jude Medical internal investigation found the probability that a damaged lead could result in the inability to deliver appropriate high-voltage therapy is very low and that any associated risks can be prevented with device reprogramming. The patients’ leads can also be monitored from home using the Merlin.net remote care system.

The company has not received any reports of compromised performance of the impacted Optisure leads. St. Jude Medical is in the process of providing an updated advisory notice to physicians to further ensure they are aware of recommendations for managing their patients who may have been implanted with the impacted leads.

The advisory notification involves the worldwide distribution of 447 Optisure dual coil defibrillation leads manufactured and distributed by St. Jude Medical. The advisory relates to units within the following models: LDA220, LDA220Q, LDA230Q, and LDP220Q.

The vast majority of patients implanted with the Optisure leads compromised by the advisory have devices equipped with the St. Jude Medical DynamicTx feature that provides additional protection to help ensure delivery of appropriate high-voltage therapy even in the case of a compromised lead. For these patients, physicians are advised to enroll patients in the Merlin.net patient care network, ensure the DynamicTx feature is programmed “on” and then monitor patients as per normal follow-up protocols.

Physicians following the nine patients in the United States with compromised leads not connected to a device with the DynamicTx feature have been advised to enroll these patients in the Merlin.net patient care network and, where appropriate, consider turning off the SVC coil. If a dual coil shocking configuration is desired, physicians should consider performing a high-voltage test when clinically appropriate to determine whether the lead has been compromised. As of this letter all physicians following the nine patients have been contacted and provided information about this event.

St. Jude Medical has alerted all physician customers impacted by the advisory by letter and all leads subject to this advisory have been accounted for and none remain in any field distribution. The U.S. Food and Drug Administration and other regulatory bodies have been notified.

For more information: www.sjm.com

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