Implantable pacemakers.Medtronic Kappa® 600/700/900 series and Sigma® 100/200/300 series IPGs.Specific serial numbers may be entered online to determine if they are affected (http://KappaSigmaSNList.medtronic.com).
Dr David Dunham
Medtronic Limited
Suite One
Sherbourne House
Croxley Business Centre
Watford
WD18 8WW
Tel: 01923 212 213
Fax: 01923 241 004E-mail: david.dunham@medtronic.com
“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.