Boston Scientific Neuromodulation Corporation is recalling the surgical implant manual for Vercise Deep Brain Stimulation (DBS) systems, affecting approximately 25,260 units. The recall was initiated because wire breaks have occurred in rechargeable implantable pulse generators when they are placed in the submuscular pectoral location. These breaks can stop the device from working correctly, which may require surgery to remove or replace the implant.
A broken wire prevents the device from delivering stimulation therapy, which can lead to a return of symptoms, undesired sensations, or connectivity issues. If a wire break occurs, the patient will likely require surgical intervention to replace the medical device.
Recall specifically concerns wire breaks occurring when rechargeable pulse generators are implanted in the submuscular pectoral location.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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