BEUDAMED
    FDA Recall Terminated

    Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

    Recall: Z-0396-05 · Initiated November 11, 2004

    Recall

    Recall Number
    Z-0396-05
    Event Number
    30494
    Firm
    Advanced Bionics Corporation
    FEI Number
    1000220815
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2004
    Posted
    January 15, 2005
    Terminated
    March 8, 2005
    Address
    12740 San Fernando Rd, Sylmar, CA, 91342-3728

    Description

    Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

    Reason

    A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

    Action

    Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.

    Distribution

    Nationwide

    Quantity

    237 patients are implanted.