ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2020. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE THE PATIENT IS STILL USING THE PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002242816-2020-00012 AND 0002242816-2020-00013. THE DEVICE WAS NOT RETURNED.
D
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE SPINALPAK STIMULATOR. THE PATIENT WAS USING THE SPINALPAK STIMULATOR WITH THE LT-4500 AND 72R ELECTRODES. THE PATIENT STATED THAT THE PAIN WAS ON THE RIGHT SIDE OF HER BACK IN THE KIDNEY AREA AND ACROSS THE HIP. THE PATIENT STATED THAT THE PAIN IS BELOW THE SKIN AND THE PAIN LEVEL IS A 10, ON A SCALE OF 1-10. THE PATIENT STOPPED USING THE STIMULATOR AND THE PAIN DID NOT GO AWAY. THE PATIENT CALLED THEIR DOCTOR AND WAS PRESCRIBED IBUPROFEN AND ADVISED NOT TO USE THE STIMULATOR FOR A WEEK. THE PATIENT BELIEVES THAT THE PAIN WAS FROM THE INFLAMMATION OF THE INCISION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.