Recall of Neuromodulation systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0022-2018
  • Event Initiated Date
    2017-09-12
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • 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

Device

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
  • Product Description
    Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
  • Manufacturer

Manufacturer

  • Manufacturer Address
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA