Description of Event or Problem · 0
DUE TO MY NEGATIVE EXPERIENCE WITH AN IMPLANTED SPINAL CORD STIMULATOR (SCS), I AM WRITING THIS LETTER TO EXPRESS MY CONCERN ABOUT THE LACK OF ADEQUATE LEGALLY REQUIRED DISCLOSURE OF COMMON SIDE EFFECTS AND THE RESULTING SERIOUS PROBLEMS THAT CAN RESULT FROM THESE DEVICES. BACKGROUND: IN (B)(6) 2021, 1 HAD A SURGERY TO IMPLANT A PERMANENT SCS IN MY BACK FOR CHRONIC PAIN LIKELY CAUSED BY FAILED BACK SURGERY SYNDROME. THE DEVICE I RECEIVED IS MANUFACTURED BY NERVO CORP. OF REDWOOD CITY, CALIFORNIA. MY IMPLANTED SCS DEVICE WORKED FAIRLY WELL FOR ABOUT ONE YEAR. THEREAFTER, I EXPERIENCED INCREASING FREQUENCY OF NEEDING TO CHANGE SPINAL STIMULATION PROGRAMS AND/OR POWER LEVELS. FINALLY, RECEIVING NO RELIEF FROM THE NERVO SCS ON ANY SETTING, I TURNED IT OFF AS I DISCOVERED THAT THE DEVICE CAUSES PAIN RATHER THAN PROVIDING PAIN RELIEF. I NOW LIVE WITH BACK AND LEG PAIN AT LEAST AS SEVERE AS BEFORE THE SCS IMPLANT AND VIABLE OPTIONS TO CORRECT OR MITIGATE SEEM TO BE FEW. TO THEIR CREDIT. THE DOCTOR DOING THE SURGERY AND NERVO CORP. FOLLOWED ALL APPLICABLE PROTOCOLS AND REQUIRED DISCLOSURES ESTABLISHED BY THE FDA AND OTHER AGENCIES PRIOR TO INSTALLATION OF THE SCS IMPLANT. MY CONCERN IS THAT THE REQUIRED DISCLOSURES AND PRE-SURGICAL CONSULTATIONS ARE SO MINIMAL THAT THEY PROVIDE VIRTUALLY NO INFORMATION ABOUT COMMON PROBLEMS OF WHICH PTS SHOULD BE AWARE PRIOR TO CONSIDERING THIS SURGERY. REFER TO ADDITIONAL DOCUMENTS IN I2K¿.