SOFTWAVE

Description of Event or Problem

ON (B)(6) 2026, I UNDERWENT SOFTWAVE EXTRACORPOREAL SHOCKWAVE THERAPY APPLIED OVER THE SACRAL REGION AT STRETCH AFFECT. PRIOR TO TREATMENT, I DISCLOSED IN WRITING AND VERBALLY A COMPLEX SPINAL AND NEUROLOGIC HISTORY INCLUDING: COMPLETE L5-S1 DISC FAILURE EFFACING THE DORSAL ROOT GANGLION WITH CHEMICAL RADICULITIS; DURAL ECTASIA SECONDARY TO CONNECTIVE TISSUE DISEASE; TARLOV (PERINEURAL) CYSTS INCLUDING AN S3 CYST; SACRAL ALLODYNIA WITH PELVIC NERVE INVOLVEMENT; PRIOR TO TREATMENT, MY SYMPTOMS WERE STABLE, PREDICTABLE, AND PRIMARILY POSITIONAL/PRESSURE DEPENDENT, WITH MINIMAL TO NO PAIN AT REST. FOLLOWING THE (B)(6) 2026 TREATMENT, I EXPERIENCED A SIGNIFICANT AND PERSISTENT DETERIORATION FROM BASELINE INCLUDING: SEVERE NEUROPATHIC PAIN, EXPANDED SACRAL AND PELVIC NERVE DISTRIBUTION, NEW BURNING NEUROPATHIC PAIN AT REST, PAINFUL NERVE PULSES RADIATING INTO HIGHLY SENSITIVE PRIVATE/PELVIC REGIONS NOT PREVIOUSLY INVOLVED, NEW BURNING SENSATIONS IN THE LEGS, INCLUDING CUTTING SENSATIONS, TWITCHING, AND PAINFUL NERVE PULSES, PROGRESSIVE PRESSURE INTOLERANCE AFFECTING SITTING, LYING DOWN, AND WALKING, PERSISTENT BUZZING SENSATIONS ALONG NEW NERVE PATHWAYS AND A SIGNIFICANT DETERIORATION IN MY FUNCTIONAL CAPACITY. THE SYMPTOMS DEVELOPED AFTER TREATMENT AND HAVE PERSISTED FOR NOW 3.5 MONTHS WITHOUT RETURN TO BASELINE. 14 DAYS OF STEROIDS DID NOT RESOLVE SYMPTOMS. I LATER BECAME CONCERNED THAT EXTRACORPOREAL SHOCKWAVE THERAPY OVER THE SACRUM MAY HAVE BEEN CONTRAINDICATED GIVEN MY KNOWN TARLOV CYSTS, DURAL ECTASIA, ACTIVE CHEMICAL RADICULITIS, AND VULNERABLE SACRAL NERVE STRUCTURES. BOTH PROVIDER AND DEVELOPER OF TECHNOLOGY DENY THIS. I NOTIFIED THE PROVIDER IN WRITING ON (B)(6) 2026 AND AGAIN ON (B)(6) 2026 DOCUMENTING ONGOING AND WORSENING SYMPTOMS. THE PROVIDER REPORTEDLY CONSULTED A SOFTWAVE ADVISOR, AND I WAS INFORMED CONTINUED TREATMENT WAS RECOMMENDED, WHICH BOTH I AND THE PROVIDER BELIEVED WOULD BE CONTRAINDICATED GIVEN THE REACTION. CURRENT STATUS: AS OF (B)(6) 2026, I CONTINUE TO EXPERIENCE DISABLING NEUROPATHIC SYMPTOMS AND SUBSTANTIAL FUNCTIONAL DECLINE COMPARED TO PRE-TREATMENT BASELINE. I RECEIVED THE TREATMENT (B)(6).