Optisure Defibrillator Leads
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What is an Optisure Dual-Coil Defibrillator Lead?
Optisure leads are thin, insulated wires used with implantable cardioverter defibrillators (ICDs). ICDs are used to treat heart rhythm disorders like ventricular fibrillation, arrhythmias, and tachycardia.
Who Makes Optisure Defibrillator Leads?
The manufacturer of Optisure Defibrillator Leads is St Jude Medical, a medical device manufacturer headquartered in Minnesota.
How Does a Defibrillator Lead Work?
The ICD monitors the patient’s heart rate. If the heart rate is erratic, or too fast, the Optisure leads deliver an electrical current from the ICD to the heart to restore normal heart rate.
Why did the FDA issue a Class 1 Recall of Optisure Dual-Coil Defibrillator Leads?
The FDA issued its Class 1 Advisory after St. Jude Medical sent a letter to doctors in November advising that several hundred of its Optisure dual-coil defibrillator leads may not work. St. Jude Medical told doctors that the problem may have occurred during a manufacturing process to trim excess medical adhesive. That process may have damaged the protective coating on the leads. A Class 1 recall means the FDA believes using one of the devices could result in serious health consequences.
Which Leads Were Recalled?
The model numbers associated with the recall are LDA220, LDA220Q, LDA230Q, and LDP220Q. The total number of Optisure Dual-Coil Defibrillator Leads recalled worldwide is 447; of those, 278 were distributed in the U.S.
What are the Possible Injuries from Defective Optisure Leads?
According to the FDA “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.” Simply put, the defibrillator might not work, and the patient may suffer any medical consequence that their heart condition may inflict.
What can you do?
If you have experienced symptoms you believe are related to your ICD, seek medical attention immediately. If you have been injured by a defective Optisure defibrillator lead and would like legal advice, contact the experienced medical device attorneys at Thornton Law Firm. Call 1-888-341-1405 and ask to speak with Attorney Marilyn McGoldrick, or tell us your story using our online form. All legal claims have short time limits, so seek advice as soon as you are able. The consultation is free and completely confidential.