Events

Safety Alert for Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Inc.; MEDTRONIC COMERCIAL LTDA.

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
    2265
  • Date
    2017-04-12
  • 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
    Medtronic does not recommend the prophylactic replacement of SynchroMed II pumps with the previous battery design because of the estimated low occurrence rate, the presence of pump alarms, and the risk associated with replacement surgery. This opinion has been reviewed and is supported by the panel of specialized external physicians. However, proper consideration should be given to the medical needs of each patient. When critical and non-critical alarms listed below occur, Medtronic strongly recommends that replacement surgery be scheduled as quickly as possible for these patients.
  • Reason
    This notice provides an update to information previously reported to physicians in july 2011 regarding the reduced battery performance failure rate on the medtronic model 8637 synchromed® ii pump manufactured as of june 2011 (medtronic's reference: fa522). this notification reinforces previously reported patient treatment recommendations regarding this problem. this notification does not apply to currently distributed or deployed synchromed ii devices or to any device manufactured after june 2011. in latin america, medtronic began distributing the synchromed ii pumps with a new battery design in july 2011.
  • Action
    Field Action Code FA760 released under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will update, correct or supplement the instructions for use.

Device

Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 A...

Manufacturer

Medtronic Inc.; MEDTRONIC COMERCIAL LTDA
  • 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