Enquiries to the manufacturer or the National Pacing and ICD Database should be addressed to:David G Dunham BSc PhD Regulatory Affairs Manager - UK & Ireland, Medtronic Ltd, Suite One, Sherbourne House, Croxley Business Centre, Watford WD18 8WWTel: 01923 212 213E-mail: david.dunham@medtronic.comNational Pacing and ICD Database, PO Box 9205, Bridge of Weir, Strathclyde, PA11 3DZTel: 01505 612 829 Fax: 01505 612 829E-mail: mwc@btconnect.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.