The lead caps available in Medtronic Deep Brain Stimulation dystonia therapy kits and lead kits have been recalled due to the potential damage that could be had in said component. Medtronic announced the recall following the discovery that connector twisting in the midst of a brain operation could lead to said damage. This could compromise the patient’s ability to receive adequate therapy. Medtronic has submitted a proposed alteration to the manufacturing procedure that they hope to receive FDA approval of. In the meantime, doctors are being instructed on how to properly use these devices, and if any adversity is presented, a report should be filed with MedWatch.
To learn more about the recall, click here.