Recall of Device Recall Proclaim Elite SCS IPG

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
    77509
  • Event Risk Class
    Class 2
  • Event Number
    Z-2691-2017
  • Event Initiated Date
    2017-06-02
  • 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
    The firm discovered a risk of loss of neuromodulation therapy due to exposure of the ipg to monopolar electrosurgical devices (esu) during medical procedures.
  • Action
    The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.

Device

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO || Product Usage: || The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • 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