Description of Event or Problem · 0
UNANTICIPATED PAIN EVENT; BEGAN USING SPINALSTIM (ORTHOFIX) BONE GROWTH STIMULATOR (AFTER FULL LUMBAR FUSION ANCHORING INTO SACRUM - S2- AND LOWER ILIA, BOTH SIDES) IN EARLY (B)(6). HAD INITIAL PAIN REACTION +/- 1 WEEK AFTER STARTING. STOPPED USE FOR A DAY AND RESUMED. ONE WEEK LATER MORE SEVERE PAIN STARTED. STOPPED USE FOR 2-3 DAYS AND THEN RESUMED, ON COUNSEL FROM COMPANY REP. MAJOR PAIN ISSUES BEGAN ABOUT A WEEK LATER. STOPPED USE FOR 2 WEEKS PLUS AND THEN RESUMED. EXACTLY 2 WEEKS LATER PAIN ISSUES BEGAN TO MANIFEST ONCE AGAIN. ALL THE WHILE, MY CONTACT REP ASSURED ME THAT NO PAIN ISSUES HAD EVER BEEN REPORTED. FDA WARNING (IN THE SMALL PRINT) LISTED "INCREASED PAIN" AS FIRST ISSUE TO BE WARNED OF. PAIN ISSUES OCCURRED AT OR NEAR SURGICAL FUSION SITE SOMEWHAT, BUT MORE OFTEN AT LOCATIONS NOT RELATED TO SURGICAL AREA. MAJOR PAIN OCCURRED AT TOP OF RT. ILIAC CREST AND IN MUSCLES ABOVE HIP / WAIST. PAIN ALSO MANIFESTED IN LOWER ABDOMINAL CAVITY AND ALSO OCCURRED AS SINGULAR PAIN MANIFESTATION AT LOWER RT. ILIAC EDGE DESCENDING TO SITZ BONE AREA. PERCEIVED INFLAMMATION WAS ALSO PRESENT IN LOWER ABDOMEN (SWELLING OF THE GUT). COMPANY REP FAITHFULLY DENIED ANY REPORTS OF PAIN ISSUES SUCH AS MINE. COULD NOT PROVIDE CLINICAL TRIAL RESULTS. KEPT ON SUGGESTING OTHER METHODS TO WEAR DEVICE / SHIELD (?) BODY AREAS, ADJUST TIME DURATION INTO SHORTER BLOCKS, BUT DID NOT ADMIT PRODUCT FAULTS. AT ONE POINT SAID THEY WOULD GLADLY REPLACE DEVICE IF I SUSPECTED MALFUNCTION, BUT DID NOT FOLLOW THROUGH WHEN PAIN KEPT ON RECURRING. NO TESTS WERE PERFORMED AS THERE ARE NO TESTS TO IDENTIFY PATIENT'S PAIN LEVELS OR LOCATION, OTHER THAN WHAT PATIENT RELATES. CT SCAN OF FULL LUMBAR FUSION AND ANCHORS + ADDITIONAL CT OF PELVIS SCHEDULED FOR (B)(6) 2022 BY DR. (B)(6) (NEURO SURGEON). FDA SAFETY REPORT ID# (B)(4).