Lead Kits, Deep Brain Stimulation (DBS™) Lead Kits
Model / Serial
Models 3387, 3387S, 3389, 3389S, 3391, 3391S
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BfArM update code :
In June 2013 Medtronic began distributing lead kits manufactured after the process changes. lead kits manufactured after the process changes can be identified by the UPN number located on the shelf box side label ( see attached) and on the device registration stickers. A document identifying new product UPN's and their location on the package is attached. Please note that the UPN is the only way to identify the corrected product.(please see attached)
“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.