Description of Event or Problem · 1
IT WAS REPORTED TO EBI BY THE PT THAT SHE HAD AN SPF SPINAL FUSION STIMULATOR (MODEL #SPF-2T/C, SERIAL #720566) IMPLANTED IN 1/92. APPROX 8 MONTHS POST-OP, AFTER THE PT HAD ACHIEVED A SUCCESSFUL FUSION AND THE DEVICE HAD EXCEEDED ITS ACTIVE BATTERY LIFE OF APPROX 26 WEEKS, THE DEVICE WAS EXPLANTED, AFTER THE PT EXPERIENCED "SHOCKING PAINS". THE PT ALSO REPORTED THAT THE BATTERY HAD "LEAKED." ONLY A SMALL PORTION OF ONE LEAD WAS RETURNED TO EBI FOLLOWING EXPLANTATION OF THE DEVICE. AN MDR REPORT WAS PREPARED FOR THIS PT COMPLAINT AND WAS SUBMITTED TO FDA ON 3/29/93 (MDR ACCESS NO. M373173). THIS REPORT WAS THE SUBJECT OF AN FDA INSPECTION, WHICH WAS CONDUCTED ON MARCH 18 AND 19, 1993, BY AN INSPECTOR FROM THE NEWARK DISTRICT OFFICE, IN RESPONSE TO A CONSUMER COMPLAINT MADE BY THE PT TO HER LOCAL FDA DISTRICT OFFICE. THIS EVENT WAS REPORTED TO EBI BY THE PT. BASED THE INFO AVAILABLE TO EBI AT THE TIME OF THIS INCIDENT, THE CONDITION OF THE RETURNED DEVICE, AND THE INABILITY TO PERFORM AN ANALYSIS OF THE DEVICE, NO CONCLUSION COULD BE DRAWN AS TO WHETHER THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT WAS OR WAS NOT ATTRIBUTABLE TO THE DEVICE. TO DATE, THERE HAVE BEEN NO KNOWN SPF DEVICE FAILURES THAT HAVE BEEN DIRECTLY ATTRIBUTED TO A PROBLEM WITH THE BATTERY/POWER SOURCE. THE OVERALL FAILURE RATE FOR THE DEVICE, BASED ON DEVICES RETURNED VS. TOTAL DEVICES SHIPPED FROM 1/1/90 TO THE PRESENT, IS APPROX 0.50%.