Events

Safety Alert for Commercial name: MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (MODEL 37714) and Generators for Spinal Cord Stimulation RM (MODEL 97714) //. ANVISA registration number: 10339190310 and 10339190453 //. Technical Name: IMPLANTABLE PULSE GENERATOR FOR NEUROSTIMULATION //. Risk class: IV - Maximum risk //. Affected Models: MODELS 37714 (Registry 10339190310) and 97714 (Registry 10339190453) //. Serial numbers affected: Attached list

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA; MEDTRONIC PUERTO RICO OPERATIONS CO.; MEDTRONIC NEUROMODULATION; MEDTRONIC INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1918
  • Date
    2016-05-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Advice to Health Professionals to guide patients to follow the current instructions for recharging the RestoreSensor implantable neurostimulator, paying close attention to the Indicators of Charge Efficiency and Battery Charge Level in the charger. #### UPDATED ON 7/24/2017, the company submitted the field action completion report verifying the sending of the customer safety notice.
  • Reason
    Medtronic has confirmed four episodes of loss of therapy during the recharge of an implantable restoresensor neurostimulator with an incidence of 0.007% of the devices distributed worldwide. at conception, pacing therapy is discontinued when the battery voltage drops below 3.575 volts. in the reported occurrences, a charging session was terminated before reaching a recharge threshold of 3.615, which triggered a rapid state of battery depletion. as a result of the rapid state of battery discharge, the implanted neurostimulators ran out at 1,925 volts (a state of excessive discharge) in one or two days instead of the normal 30 days. the incorrect positioning (load efficiency) between the charger and the neurostimulator implanted during the recharge session proved to be an important factor in the reported events.
  • Action
    Field Action is an Orientation for Health Professionals. Code: FA 709. Recommendations: Communicate patients to follow the current instructions for recharging the RestoreSensor implantable neurostimulator, paying close attention to the Indicators of Load Efficiency and Load Level the battery. • Check the charge level of the neurostimulator battery once a day or more often if necessary. • Keep the neurostimulator sufficiently charged to maintain therapy. It can be loaded at any time; it is not necessary to wait for the low battery message. • While recharging the neurostimulator, monitor the Charge Efficiency line and position the antenna to get as many solid black boxes as possible. If only two black boxes are filled (6 or more boxes are empty), reposition the antenna to improve signal strength between the neurostimulator and the charger. • During recharging, make sure the Neurostimulator Battery Charge Level is at least 25% before the end of the charging session. However, a full battery charge is ideal.

Device

Commercial name: MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (MODEL 37714) and Generators for Spinal C...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC PUERTO RICO OPERATIONS CO.; MEDTRONIC NEUROMODULATION; MEDTRO...
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA