Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE ON (B)(6) 2013 NOTED THAT THE PATIENT FOLLOWED UP ON (B)(6) 2011 COMPLAINING OF FEVER AND PAIN. ON (B)(6) 2011, THE PATIENT COMPLAINED TO THE PHYSICIAN OF HAVING RECTAL PRESSURE; ESPECIALLY WHEN LYING DOWN. ON (B)(6) 2011, SHE INFORMED THE DOCTOR THAT SHE EXPERIENCED LEFT PELVIC PAIN WHEN MOVING CERTAIN WAYS; THE LEFT ARM OF THE SOLYX DEVICE WAS BULGING. ON (B)(6) 2011, THE PATIENT FOLLOWED UP WITH THE DOCTOR NOTING PAIN WHILE SITTING AND BENDING, ALONG WITH RECTAL PRESSURE. THE RIGHT AND LEFT ARMS OF THE SOLYX DEVICE WERE BULGING CREATING PAIN. THE PHYSICIAN REFERRED THE PATIENT TO A UROGYNECOLOGIST. THE PATIENT WAS LAST SEEN IN (B)(6) 2011 WITH SEVERE PAIN. SHE WAS GIVEN PAIN MEDICATION WHICH SHE WAS TAKING EVERY 2 HOURS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.