Which Boston Scientific devices are part of the case?
The case groups lawsuits from people who say a Boston Scientific implant hurt them. The panel’s order lists no models. In the lawsuits we read, people say they had one of four models, such as the WaveWriter Alpha.
The companies sued are Boston Scientific Corp. and Boston Scientific Neuromodulation Corp. Each person in the group says they had one of its stimulators placed and were hurt. The device makers argued that each case involved different devices and injuries. The panel did not agree and grouped the cases.
The model names come from individual lawsuits, so they are claims, not a court list. In one lawsuit, the person says they had a WaveWriter Alpha. In others, people say they had a Spectra WaveWriter, a Precision Spectra or a Precision Montage MRI. The lawsuits also name older models, such as the Precision Plus.
These lawsuits say the newer models trace back to one FDA approval. That approval, number P030017, covered the Precision system in April 2004. The lawsuits say later models came through add-on approvals, called supplements.