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. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS MAY OF 2025.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED SKIN IRRITATION WHILE USING 72R ELECTRODES. THE PATIENT STATED THAT THE 72R ELECTRODES ARE CAUSING THE RED SPOTS AND WELTS, THERE ARE NO BLISTERS. THE ELECTRODES ARE CHANGED EVERY 2 TO 3 DAYS. BY THE THIRD DAY THE ITCHINESS AND BURNING SENSATION STARTS. THE AREA IS CLEANED WITH SOAP AND WATER. THE PATIENT USES WIPES SOMETIMES, NO NEW PRODUCT. THE PATIENT HAS SENSITIVE SKIN. THE PATIENT IS ALLERGIC TO PENICILLIN, DEMEROL, MORPHINE AND GABAPENTIN. THE PATIENT DID APPLY CORTISONE CREAM ON THE AFFECTED AREA. THIS IS USED EVERY NIGHT. THE PATIENT DID NOT SPEAK TO HER DOCTOR. THE PATIENT HAS NOT USED THE DEVICE FOR FOUR DAYS. THE PATIENT STATED THAT SHE FEELS LIKE ELECTRICITY IS GOING FROM HER LEFT HOP DOWN THE LEFT LEG. THE PATIENT HAD A C2 TO T8 FUSION. THE PATIENT DID THEN SPEAK TO HER DOCTOR AND WAS TOLD NOT TO USE THE STIMULATOR. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED SKIN IRRITATION WHILE USING 72R ELECTRODES. THE PATIENT STATED THAT THE 72R ELECTRODES ARE CAUSING THE RED SPOTS AND WELTS, THERE ARE NO BLISTERS. THE ELECTRODES ARE CHANGED EVERY 2 TO 3 DAYS. BY THE THIRD DAY THE ITCHINESS AND BURNING SENSATION STARTS. THE AREA IS CLEANED WITH SOAP AND WATER. THE PATIENT USES WIPES SOMETIMES, NO NEW PRODUCT. THE PATIENT HAS SENSITIVE SKIN. THE PATIENT IS ALLERGIC TO PENICILLIN, DEMEROL, MORPHINE AND GABAPENTIN. THE PATIENT DID APPLY CORTISONE CREAM ON THE AFFECTED AREA. THIS IS USED EVERY NIGHT. THE PATIENT DID NOT SPEAK TO HER DOCTOR. THE PATIENT HAS NOT USED THE DEVICE FOR FOUR DAYS. THE PATIENT STATED THAT SHE FEELS LIKE ELECTRICITY IS GOING FROM HER LEFT HOP DOWN THE LEFT LEG. THE PATIENT HAD A C2 TO T8 FUSION. THE PATIENT DID THEN SPEAK TO HER DOCTOR AND WAS TOLD NOT TO USE THE STIMULATOR. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

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.