BEUDAMED
    FDA Recall Terminated

    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

    Recall: Z-0023-2018 · Initiated September 12, 2017

    Recall

    Recall Number
    Z-0023-2018
    Event Number
    78154
    Firm
    St. Jude Medical, Inc.
    FEI Number
    1627487
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 12, 2017
    Terminated
    April 16, 2020
    Address
    6901 Preston Rd, Plano, TX, 75024-2508

    Description

    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

    Reason

    Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

    Action

    St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following: Phase I: ERI Assessment If a patient reports that an ERI message is displayed on the PC, please contact your Abbott Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps in Appendix B prior to making an elective replacement decision. After the ERI Assessment is completed, follow-up communication from your Abbott representative will be provided in order to make appropriate decisions. The response will be one of two possible responses: o ERI is valid at this time for this device, follow existing information provided by IFU and CP for the elective replacement window for this device. o The device has the appropriate level of battery voltage to provide the existing therapy until the next assessment, which should occur no later than March 2018. During this period, the ERI message will be displayed on the PC at the start of each session. This message may be dismissed to enter the session on the PC. Phase II: ERI Software Update Abbott will deploy a software upgrade, upon approval by local governing agencies that addresses the errors in calculation causing the inappropriate ERI message. When this software update is deployed, the Phase I ERI assessment process is no longer needed. After the CP is updated, replacement decisions can be made following the revised instructions for use, which will be available at manuals.sjm.com. Once approved for use in your area, notification of the availability of this software update will occur through the Apple Public App Store for the PC and through the SJM App Catalog for the CP. Should you have questions about patient management, including questions regarding error messages related to IPGs, please contact your local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S) and +46 8 474 414

    Distribution

    Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)

    Quantity

    3,119 devices