BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3021741 · Received March 26, 2013

    Report

    Report Number
    3005099803-2013-01715
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, DURING THE FIRST POST-OPERATIVE VISIT ON (B)(6), 2009, THE PATIENT REPORTED A 'BULGE AT HER VAGINA,' BUT INCONTINENCE HAD IMPROVED. THE EXAMINATION WAS NORMAL. DURING THE SECOND POST-OPERATIVE VISIT ON (B)(6) 2009, THE PATIENT COMPLAINED OF EPIGASTRIC AND SUPRAPUBIC PAIN AS WELL AS URINARY FREQUENCY BUT DENIED INCONTINENCE AND HESITANCY. IT WAS REPORTED THAT THE EPIGASTRIC AND SUPRAPUBIC PAIN WAS PRESENT INTERMITTENTLY PRIOR TO SURGERY AND THE PHYSICIAN BELIEVES IT IS NOT SURGICAL IN NATURE OR RELATED TO THE URINARY TRACT. THE EXAMINATION WAS NORMAL. URODYNAMIC TESTING WAS PERFORMED (RESULTS UNKNOWN). DURING THE THIRD POST-OPERATIVE VISIT ON (B)(6) 2010, THE PATIENT COMPLAINED OF A URINARY TRACT INFECTION AND RECURRENT ABDOMINAL PAIN. MINIMAL SPOTTING OF URINE BUT NO REAL LEAKING AND NO URINARY COMPLAINTS WERE REPORTED. URINE CULTURES HAD BEEN NEGATIVE AND A URINARY TRACT INFECTION WAS REPORTED TO BE UNLIKELY. DURING A FOURTH POST-OPERATIVE VISIT ON (B)(6) 2010, THE PATIENT COMPLAINED OF URINARY RETENTION, WHICH RESOLVED. THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY ONE WEEK PRIOR, THEN HAD POST-OPERATIVE RETENTION WITH PLACEMENT OF A FOLEY CATHETER. THE PATIENT DENIED INCONTINENCE, URGENCY, AND FREQUENCY. DURING A FIFTH POST-OPERATIVE VISIT ON (B)(6), 2011, THE PATIENT COMPLAINED OF INCONTINENCE. THE PATIENT WAS ONE MONTH POST-PARTUM AND REPORTED LEAKAGE AT NIGHT UPON WAKING. THE PATIENT STATED THAT THIS IS HOW THE PREVIOUS STRESS INCONTINENCE INITIALLY BEGAN. THE PHYSICIAN NOTED THAT THE INCONTINENCE SEEMED TO ACTUALLY BE URGE INCONTINENCE. THE PHYSICIAN REPORTED THAT THE SLING MAY NO LONGER BE IN GOOD POSITION FOLLOWING THE PATIENT'S PREGNANCY AND VAGINAL DELIVERY. VESICARE WAS PRESCRIBED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123423 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention