Description of Event or Problem · 0
SEE ATTACHED "SAVED TO PHOTOS" AS PREVIOUSLY UNABLE TO SEND. WEARING ORTHOFIX ELECTROMAGNETIC BELT FO 2 HRS EACH DAY AS PRESCRIBED BY MY NEUROSURGEON, DR VILLANUEVA. FOR HELP IN FURTHER "FUSING" POST SURGICAL L3 THRU S2. WORE FOR 3.5 WEEKS AND NOTED ON TWO DIFFERENT OCCASIONS, THAT THE BELT WOULD BEGIN A RAPID SOFT TICKING SOUND WHEN I WAS PLACING LAUNDRY INTO MY WASHING MACHINE (NOT RUNNING) AT AROUND WEEK 2.5 SEVERAL DAYS LATER IT DID THE SAME SOFT RAPID TICKING SOUND AGAIN WHEN NEAR THE DRYER (ALSO NOT ON, BUT POSSIBLY PRIMED). AND THEN AFTER ABOUT 3.5 WEEKS OF USE (FORGOT TO WEAR A FEW DAYS IN BETWEEN) I WAS COMFORTABLY SITTING IN MY LEATHER PUSHBACK RECLINER (AS I HAD DONE WHILE WEARING THE BELT ALMOST EVERY USE), AND THE ORTHOFIX BELT, AGAIN STARTED THE RAPID SOFT TICKING/ CLICKING SOUND, BUT THIS TIME IT DELIVERED AN ELECTRIC TYPE PAINFUL SHOCK TO MY LEFT POSTERIOR WAIST DOWN TO BUTTOCK, FOLLOWED INSTANTLY WITH AN EXCRUCIATING SPASM PAIN OF MY LEFT HAMSTRING. I IMMEDIATELY RIPPED OFF THE BELT AND TOSSED IT SAFELY TO ANOTHER CHAIR. AND ATTEMPTED TO MASSAGE AND SCREAM IN PAIN AS MY LEFT HAMSTRING MUSCLE CONTACTED FOR 10 MINUTES, BEFORE I WAS ABLE TO MASSAGE AND STRETCH IT TO STOP THE PAIN. IF I HAD TO GAUGE, IT WAS THE MOST EXCRUCIATING PAIN I HAD EVER FELT AND WAS 100 ON THE PAIN SCALE. MY HUSBAND WAS WITH ME AND LOOKED ON IN HORROR. I CONTACTED MY ORTHOFIX REP, SCOTT GROSPITCH, WHO HAD DELIVERED AND PLACED THE BELT ON ME THE FIRST TIME WITH INSTRUCTIONS. I HAD PREVIOUSLY RESEARCHED THE BELT AND ASKED MY PHYSICAL THERAPIST ABOUT IT. SHE HAD NOT HEARD OF IT. BUT WAS AWARE OF AC AND DC USE OF TENS TYPE TREATMENTS TO HELP DECREASE PAIN AND SPASM. HOWEVER, THIS WAS DIFFERENT, AND AFTER SCOTT'S ADVICE TO CALL ORTHOFIX CUSTOMER SERVICE. I SPOKE WITH LETICIE AT THE AMARILLO, TX OFFICE. SHE SAID THAT SHE "COULD NOT ADVISE PATIENTS WHO HAD BEEN SHOCKED BY THE BELT". ASTOUNDED, I ASKED HAD THIS HAPPENED TO PTS BEFORE AND SHE SAID "YES". SHE FURTHER ADMITTED THIS DEVICE HAS FDA APPROVAL. THEN I SAID I INITIALLY WAS CALLING PER SCOTT TO SEE IF I COULD TRY EXCHANGING ANOTHER BELT AND TO HAVE THIS ONE "AUTOPSIED" TO SEE WHAT WENT WRONG. BUT AFTER HEARING THIS HAD HAPPENED BEFORE, DID NOT WANT ANOTHER BELT. LETICIE PUT ME ON HOLD TO FIND OUT HOW MY BELT COULD BE RETURNED VIA UPS PICK UP. BUT LATER CAME BACK ON PHONE TO SAY A SUPERVISOR WOULD BE CONTACTING ME. I AM A NEWLY RETIRED PHYSICIAN ASSISTANT, AND DO NOT WANT THIS PAINFUL EXPERIENCE TO HAPPEN TO ANYONE ELSE. PLEASE ADVICE WHAT YOU CAN DO TO HELP.