PERIPHERAL NERVE STIMULATOR

Description of Event or Problem

THE PATIENT HAD A PERIPHERAL NERVE STIMULATOR. IT DID NOT HAVE A FUNCTIONING BATTERY BECAUSE THE BATTERY EXPIRED AND NEVER WAS REPLACED. WHEN THE BATTERY USED TO WORK, THE PATIENT ONLY RECEIVED PARTIAL COVERAGE FROM THE DEVICE. THE HEALTHCARE PROVIDER OPTED TO USE DRG STIMULATION (ALSO NOT A MEDTRONIC PRODUCT, MANUFACTURER UNKNOWN) TO TREAT THE PATIENT'S CONDITION, BUT BECAUSE OF THE PATIENT'S ANATOMY, THEY COULDN'T IMPLANT THE DRG DEVICE. THE HEALTHCARE PROVIDER REMOVED THE PERIPHERAL NERVE STIMULATOR DURING THE DRG IMPLANT SURGERY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).