Medtronic Inc. Announces Class I Recall of Neurostimulation Lead Due to Manufacturing Defect in StimLoca Burr Hole Cap

China Net Finance, July 28 -- Yesterday, the National Medical Products Administration (NMPA) issued an announcement regarding Medtronic's voluntary recall of the implantable neurostimulation lead.

The announcement indicates that Medtronic (Shanghai) Management Co., Ltd. has reported that, due to manufacturing issues involving specific models and batches, additional protrusions may appear on the edges of the retaining clips in certain batches of the StimLoca Burr Hole Cover, which could potentially affect the normal use and performance of the product. The manufacturer, Medtronic Inc., has initiated a voluntary recall of the Implantable Neurostimulation Lead (Registration Certificate No.: Imported Medical Device Registration 20163212970). This recall is classified as Class I.

It is understood that the implantable deep brain stimulation electrode is indicated for bilateral stimulation of the globus pallidus internus (GPi) or the subthalamic nucleus (STN) as an adjunctive therapy to reduce certain symptoms of advanced levodopa-responsive Parkinson's disease that are not adequately controlled with medication, and for unilateral thalamic stimulation to suppress upper extremity tremor in patients diagnosed with essential tremor or Parkinsonian tremor, for whom medication alone is insufficient to control the condition and whose tremor results in significant functional disability. StimLoca is a single-use sterile burr hole cover for use following cranial surgery.