BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED HOWEVER, NO DISCREPANCIES WERE FOUND. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT STOPPED USING THE DEVICE AS SHE HAD A REACTION THAT JACKED UP HER NERVES IN THE FEET AND ANKLES. THE PATIENT SPOKE WITH THE DOCTOR'S OFFICE, AND THEY ADVISED HER TO REMOVE IT. THE PATIENT INDICATED THAT THEY REACHED OUT TO SALES REPRESENTATIVE AND WERE ADVISED TO CONDUCT TIME-TEST. THE SALES REPRESENTATIVE SPOKE WITH THE PATIENT AND STATED THAT SHE HAD STOPPED THE TREATMENT. THE PAIN IN HER FEET AND ANKLES ARE STILL PRESENT. PATIENT IS CONCERNED IF THE STIMULATOR ELEVATED THE NEUROPATHY PAIN THAT SHE HAS. THE PATIENT HAS DECIDED THAT SHE CAN NO LONGER DO THE TREATMENT AND WOULD LIKE TO RETURN THE DEVICE. LATER, CUSTOMER SERVICE CALLED THE PATIENT. THE PATIENT CALLED BACK AND STATED THAT SHE HAS NEUROPATHY. SHE DID NOT SPEAK WITH HER DOCTOR AFTER HER INITIAL CALL; HOWEVER, SHE HAD AN APPOINTMENT LATER THAT WEEK. THE PATIENT TREATED FOR 4 DAYS WITH NO ISSUES, ON DAY 5 HER NERVE PAIN WAS AN 8 OUT OF 10. THE PATIENT TRIED TO TREAT FOR 15 MORE MINUTES AND WAS NOT ABLE TO TREAT. THE PATIENT TOOK OFF THE UNIT AND WITHIN 1 HOUR HER PAIN HAD SUBSIDED. NO FURTHER CONSEQUENCES WERE REPORTED. SPINAL PAK ASSEMBLY WAS NOT RETURNED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - H4: DEVICE MANUFACTURE DATE, H6: METHOD, RESULTS, CONCLUSIONS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT STOPPED USING THE DEVICE AS SHE HAD A REACTION THAT JACKED UP HER NERVES IN THE FEET AND ANKLES. THE PATIENT SPOKE WITH THE DOCTOR'S OFFICE, AND THEY ADVISED HER TO REMOVE IT. THE PATIENT INDICATED THAT THEY REACHED OUT TO SALES REPRESENTATIVE AND WERE ADVISED TO CONDUCT TIME-TEST. THE SALES REPRESENTATIVE SPOKE WITH THE PATIENT AND STATED THAT SHE HAD STOPPED THE TREATMENT. THE PAIN IN HER FEET AND ANKLES ARE STILL PRESENT. PATIENT IS CONCERNED IF THE STIMULATOR ELEVATED THE NEUROPATHY PAIN THAT SHE HAS. THE PATIENT HAS DECIDED THAT SHE CAN NO LONGER DO THE TREATMENT AND WOULD LIKE TO RETURN THE DEVICE. LATER, CUSTOMER SERVICE CALLED THE PATIENT. THE PATIENT CALLED BACK AND STATED THAT SHE HAS NEUROPATHY. SHE DID NOT SPEAK WITH HER DOCTOR AFTER HER INITIAL CALL; HOWEVER, SHE HAD AN APPOINTMENT LATER THAT WEEK. THE PATIENT TREATED FOR 4 DAYS WITH NO ISSUES; ON DAY 5 HER NERVE PAIN WAS AN 8 OUT OF 10. THE PATIENT TRIED TO TREAT FOR 15 MORE MINUTES AND WAS NOT ABLE TO TREAT. THE PATIENT TOOK OFF THE UNIT AND WITHIN 1 HOUR HER PAIN HAD SUBSIDED. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED.