According to a series of news reports, the Food and Drug Administration has reported that Medtronic Inc. has issued an Urgent Medical Device Correction notification concerning certain Medtronic DBS lead kits and dystonia therapy kits.
According to the federal agency, these kits could pose an adverse reaction risk linked to a potential lead damage. The FDA has indicated that this alert or notification has been classified as a Class I recall. According to the firm, reports of damage associated to the DBS lead cap were registered. According to the official report, the incidents occurred when the device was being used in surgical procedures. The company has issued different sets of instructions to surgeons and doctors using the DBS lead caps to prevent it from failing. Consumers can contact the company to learn more about this recall. At this moment, the company is trying to develop a solution to this problem. Until the solution is reported, the FDA has reported that consumers and surgeons are being urged to follow the new instructions. The FDA is now reviewing the manufacturing change of the product that was recently submitted by the company. Whenever you’re affected by a recall issued by the Food and Drug Administration, make sure that the product you have in your possession that could be potentially defective is either returned or repaired promptly. Follow instructions in order to prevent incidents or adverse reactions.
You can follow this link to read the full report if you prefer to read the announcement.