Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED (B)(6) 2009. A RIGHT LAPAROSCOPIC SALPINGO-OOPHORECTOMY WITH CYSTOSCOPY WAS ALSO PERFORMED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT'S FIRST FOLLOW-UP VISIT WAS (B)(6) 2009. THE PATIENT WAS ABLE TO VOID WELL, WITHOUT INCONTINENCE. THE PHYSICIAN PRESCRIBED TORADOL FOR POST-OPERATIVE DISCOMFORT. THE PATIENT PHONED THE PHYSICIAN (B)(6) 2009 DUE TO INCREASED PELVIC PAIN, BUT SHE REPORTEDLY CONTINUED TO VOID WELL, WITHOUT INCONTINENCE. THE PHYSICIAN PRESCRIBED PAIN MEDICATION (TYPE UNKNOWN). THE PATIENT'S SECOND POST-OPERATIVE VISIT WAS (B)(6) 2009. THE PATIENT REPORTED THAT SHE WAS STILL EXPERIENCING PELVIC PAIN AND REQUESTED TO HAVE HER LEFT OVARY REMOVED. THE PATIENT RETURNED FOR A THIRD POST-OPERATIVE VISIT (B)(6) 2009. THE PHYSICIAN PERFORMED A PELVIC ULTRASOUND WHICH REVEALED THREE CYSTS ON THE LEFT OVARY. THE PATIENT'S FINAL POST-OPERATIVE VISIT WAS (B)(6) 2010. THE PATIENT REPORTED CONTINUED PELVIC PAIN BUT SHE CONTINUED TO VOID WELL, WITH NO INCONTINENCE. SHE REPORTEDLY HAD SEEN A UROLOGIST, WHO OPINED THAT THE CAUSE OF THE PAIN WAS TIGHT PELVIC FLOOR MUSCULATURE. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.