Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN'S OFFICE, DURING A (B)(6) 2009 POST-OPERATIVE FOLLOW-UP, THE PATIENT STATED HER STRESS INCONTINENCE WAS BETTER. SHE REPORTED NOCTURIA 1X. NO DYSURIA OR FREQUENCY WAS NOTED, AND NO HEMATURIA WAS PRESENT. THE PHYSICIAN ASSESSED MIXED INCONTINENCE. THE INCISION APPEARED CLOSED AND WAS HEALING WELL. THE PATIENT WAS STILL SOMEWHAT WEAK BUT ABLE TO AMBULATE WELL. THE PHYSICIAN FELT MOST SYMPTOMS WOULD BE RELIEVED BY SOME ADDITIONAL TIME. PELVIC EXAM WAS NORMAL AND GOOD PELVIC FLOOR SUPPORT NOTED. THE PHYSICIAN DETERMINED THAT THE 16 ML OF RESIDUAL URINE WAS NOT SIGNIFICANT AND NO TREATMENT WAS NECESSARY. NO ACTIVE PROBLEMS WERE NOTED. DURING (B)(6) 2009 POST-OPERATIVE FOLLOW-UP, THE PATIENT STATED HER STRESS INCONTINENCE WAS BETTER. SHE REPORTED NOCTURIA 1X. NO FREQUENCY WAS NOTED, AND NO HEMATURIA WAS PRESENT. THE PHYSICIAN ASSESSED MIXED INCONTINENCE. THE INCISION APPEARED CLOSED AND WAS HEALING WELL. THE PHYSICIAN FELT MOST SYMPTOMS WOULD BE RELIEVED BY SOME ADDITIONAL TIME. PHYSICAL EXAMINATION NOT PERFORMED. NO ACTIVE PROBLEMS WERE NOTED. RECOMMENDED FOLLOW-UP IN ONE YEAR. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.