“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.
TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family
Affected model numbers
COGNIS CRT-D
N106/N107/N118/N119/P106/P107/P108
TELIGEN DR ICD
E110/F110/F111
TELIGEN VR ICD
E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.