BONE GROWTH STIMULATOR, SPINALSTIM

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE RETURNS AN INVESTIGATION WILL BE PERFORMED AT THAT TIME. A REVIEW OF THE DHR WAS PERFORMED AND ALL DEVICE PASSED FINAL INSPECTION.

Description of Event or Problem

AS PER PATIENT THEY REPORTED HAVING AN OUTBREAK OF HIVES AFTER SURGERY. PATIENT WAS TREATING WITH THE DEVICE AND THE HIVES GOT WORSE. PATIENT ALSO REPORTED SWOLLEN HANDS AND FEET. PATIENT TOOK A BREAK FROM TREATING PER DOCTOR RECOMMENDATION AND WHEN RESUMING TREATMENT, THE HIVES DID NOT GET BETTER. DURING A FOLLOW UP CALL PATIENT STATED SHE IS SEEING A SPECIALIST FOR THE HIVES AND HAS BEEN PRESCRIBED MEDICATION FOR TREATMENT.