BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3062290 · Received April 16, 2013

    Report

    Report Number
    3005099803-2013-02518
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN SOLYX SIS SYSTEM WAS IMPLANTED ON (B)(6),2010.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON (B)(6), 2014 NOTED THAT THE PATIENT EXPERIENCED EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC AND OTHER ACUTE AND CHRONIC NERVE DAMAGE AND PAIN, PUDENDAL NERVE DAMAGE, PELVIC FLOOR DAMAGE, AND CHRONIC PAIN. THE PATIENT ALSO HAD OPERATIONS TO LOCATE AND REMOVE MESH, OPERATIONS TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE, AND THE VAGINA, AND OPERATIONS TO REMOVE PORTIONS OF THE FEMALE GENITALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163369 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC PAH BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R