[105877777]
After undergoing lumbar back surgery on (b)(6) 2018, on (b)(6) at 1 pm, a representative of zimmer biomet came to my home while i was recovering and said my doctor had ordered a bone healing system. She applied the external system to my operative site and gave me verbal instructions on how to apply the electrodes and how to charge the unit batteries. She also left a lot of literature on the biomet spinalpak non-invasive spine fusion simulator system after it was placed on my back. At 1 am on (b)(6) 2018 i awoke from a sound sleep with the worse pain in my back running down both legs that i have ever had (and i have had some bad back pain in my life). The pain was so bad my husband called an ambulance to take me to the er. I told the attendant that on a score of 1 to 10, my pain was a 15! Once at the hospital, it became apparent that i was unable to urinate and that i could not control my bowels. I was catheterized to empty my painfully full bladder. The pain in my back was also excruciating. The first hospital i went to ((b)(6) medical center) transferred me via ambulance to the hospital where i had the surgery. At the surgical hospital ((b)(6) medical center), i was hospitalized in the step down icu for 5 days of supportive treatment, maintained the foley, and filled me full of steroids. They also administered copious amounts of narcotic pain meds as well as robaxin. I was discharged on (b)(6) 2018 without the foley, continent of stool and with tolerable pain. I was told that i had experienced an adverse event with the simulator causing abnormal swelling of my spinal cord with the attendant by products of urinary retention and incontinence of stool. I only had the simulator on my back for about 12 hours! I called the company at the number listed on the literature ((b)(6)) on about (b)(6) 2018 to report the adverse event. The first person to take my report, referred me to another person in "quality". I described the incident as i have here. The person who did not identify herself, did not ask me any questions nor did she ask me to repeat anything i said. It did not appear to me she was even taking notes. I asked if she wanted me to return the unit for testing and she said no. I asked if there had been any other reports of this kind and she said she had never heard of any. Well, if you don't write it down and even see if the unit was defective, how do you really know if you have a problem or not?
Patient Sequence No: 1, Text Type: D, B5