D
Patient 1
SERIOUS ADVERSE REACTION TO CLINICAL TRIAL OF THE DIGITAL ANGEL DEVICE. SEMI-INVALID/PARAPLEGIC CONDITION AND PAIN REQUIRING FOUR NIGHTS HOSPITALIZATION. CAUSE: ADVERSE TISSUE REACTION. SIGNAL/PRICKS FROM OPERATION AREA FOR MORE THAN 4 YEARS. SIGNAL INDUCED "PRICKS": THESE EMINATE FROM THE HERNIA OPERATION AREA IN THE LEFT GROIN WHERE THE DA WAS IMPLANTED. I HAVE FELT THESE PRICKS EVERY DAY TO THE PRESENT TIME. THE PRICKS ARE CAUSED BY IRRITATION OF THE NERVES ADJACENT TO THE IMPLANTED DEVICE. POSSIBLE REASONS FOR NERVE AGITATION: 1) EXTERNAL SIGNALS DIRECTED AT THE DEVICE. 2) INTERNALLY ACTIVATED SIGNALS. 3) ELECTROMAGNETIC INTERFERENCE. 4) THE MRI SCAN TAKEN THREE DAYS AFTER MY OPERATION MAY HAVE DAMAGED, BUT NOT DESTROYED, THE DA DEVICE CAUSING MALFUNCTIONING. THE MRI SCAN PICTURES REVEAL A TARLOVS CYST IN THE AREA WHERE TWO INJECTIONS WERE MADE INTO THE SPINE BY THE ANAESTHETIST. IT IS NOT CLEAR TO ME IF THIS CYST WAS CAUSED BY THE BURINING ACTION OF THE MRI. I MENTION THIS ONLY BECAUSE IT MAY HAVE SOME RELEVANCE TO AN INVESTIGATOR. BEFORE MY SURGICAL OPERATION AND CT, I WAS AN EXCELLENT SLEEPER. NOW EVERY NIGHT, TO THE PRESENT TIME, I AM JERKED OUT OF A DEEP SLEEP. IT IS VERY DIFFICULT TO PINPOINT THE REASON'S FOR THIS UNNATURAL DISORDER. BECAUSE OF THE MANY FEATURES OF THE DA, IT SEEMS MANY THINGS CAN GO WRONG. I AM PARTICULARLY CONCERNED WITH THE LAST SENTENCE IN THE US PT OFFICE ABSTRACT- A NOVEL SENSATION-FEEDBACK FEATURE ALLOWS THE IMPLANTEE TO CONTROL AND ACTIVATE THE DEVICE WITH CERTAINTY. THIS IS DIFFICULT TO UNDERSTAND.