BEUDAMED
    FDA Recall Terminated

    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).

    Recall: Z-0660-2016 · Initiated November 3, 2015

    Recall

    Recall Number
    Z-0660-2016
    Event Number
    72569
    Firm
    St Jude Medical Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 3, 2015
    Posted
    January 21, 2016
    Terminated
    May 10, 2019
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).

    Reason

    Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.

    Action

    An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774. A revised dear doctor letter was sent via FedEx on 1/21/16 to all affected physicians. A press release will be sent/posted on 1/22/16.

    Distribution

    Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.

    Quantity

    447 units total (281 units in US)