D
Patient 1
CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT HAD SOME ISSUES WITH HEALING AT THE INCISION SITE AFTER A LEAD AND GENERATOR REPLACEMENT. 5 DAYS POST-OP THE PATIENT HAD EXTENSIVE SWELLING AND BRUISING BUT IT WAS NOTED THAT THE CHEST WOUND WAS HEALING WELL. A MONTH AFTER IMPLANT, THE PATIENT HAD ISSUES WITH SWELLING AND TENDERNESS AT THE GENERATOR AND LEAD INCISION SITE. 5 DAYS LATER, IT WAS NOTED THAT THE WOUND WAS HEALING SATISFACTORILY AND THE SWELLING HAD DIMINISHED WITH NO SIGNS OF INFECTION. THERE WAS SOME FLUID IN THE GENERATOR SITE. THE VISIT DIAGNOSIS SECTION INDICATED "NONHEALING WOUND." CLINIC NOTES FROM A LITTLE OVER TWO MONTHS POST-OP, INDICATED THAT THE STITCHES CAME OUT AND WHEN ONE CAME OUT HIS NECK PAIN WAS BETTER. THE NOTES NOTED THAT THE WOUND LOOKED WELL-HEALED. OVER THREE MONTHS POST-OP, CLINIC NOTES REPORTED THAT HIS CERVICAL WOUND WAS HEALING BETTER WITH STILL SOME PROMINENCE AND TENDERNESS AT THE INFECTION, BUT IT WAS NOTED THAT THERE WAS SOME DRAINAGE FROM THE CHEST SITE THAT THE PATIENT DESCRIBED AS PUS-LIKE. THE DOCTOR NOTED THAT THERE WAS ERYTHEMA AROUND AN APPARENT SUTURE REACTION, BUT THERE WAS NO EVIDENCE OF INFECTION. THE AREA WAS RED BUT THE PATIENT HAD BEEN RUBBING AT THE SITE. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC OINTMENT FOR A POTENTIAL STITCH ABSCESS. A MONTH AND A HALF LATER IT WAS NOTED THAT BOTH WOUND SITES HAD HEALED WELL WITH NO DRAINAGE. THE MANUFACTURER'S DEVICE HISTORY RECORDS WERE REVIEWED FOR THE PATIENT'S LEAD AND GENERATOR. STERILITY OF BOTH PRODUCTS PRIOR TO RELEASE WAS VERIFIED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.