Boston Scientific Neuromodulation Corporation is recalling approximately 77,674 WaveWriter Alpha Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPG). These implanted medical devices, which are used to manage chronic pain, may experience an unexpected system reset during the charging process. This reset causes a temporary loss of stimulation for about 10 to 15 seconds, which can result in uncomfortable or undesired sensations for the patient. Due to these sensations, some patients have requested surgical procedures to have the device replaced or revised. This recall affects Model SC-1216 and Model SC-1232 kits distributed worldwide, including throughout the United States.
A routine system check during charging can trigger a device reset, causing therapy to suddenly stop and then restart 10-15 seconds later. This interruption can cause patients to feel unexpected and unpleasant sensations, potentially leading to the need for additional surgery to replace or fix the implanted device.
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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.
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Sources: FDA iRES · Raw API Response
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