BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 12930699 · Received December 4, 2021

    Report

    Report Number
    3005099803-2021-07247
    Event Type
    Injury
    Date Received
    December 4, 2021
    Date of Event
    June 15, 2010
    Report Date
    January 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A1: (B)(6). BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CORRECTION: A PREVIOUS REPORT FOR THIS PATIENT AND DEVICE HAS BEEN SENT UNDER MFR REPORT # 3005099803-2021-00037.

    Additional Manufacturer Narrative · 0

    (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX WAS IMPLANTED ON (B)(6) 2010. A SECOND SOLYX IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2010. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP (EROSION/EXTRUSION/PROTRUSION OF THE MESH); BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; THIGH PAIN; OTHER PAIN: BEARING DOWN PAIN; PAINFUL INTERCOURSE; INABILITY TO HAVE INTERCOURSE; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; DAMAGE; PSYCHIATRIC INJURY NONSURGICAL TREATMENTS: ON (B)(6) 2009 THE PATIENT COMMENCED PSYCHOLOGICAL MEDICATION: PRISTIQ SR 50 MG, ANTI-DEPRESSANT TO DEAL WITH UNRESOLVABLE ISSUES AS A RESULT OF MESH/TAPE INJURIES AND TRAUMA. TREATMENT DURATION: 6.5 YEARS. ON (B)(6) 2010 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): HIPREX, TO INHIBIT BACTERIAL GROWTH IN BLADDER. TREATMENT DURATION: 12 MONTHS. DEVICE 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX WAS IMPLANTED ON (B)(6) 2010. A SECOND SOLYX IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2010. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP (EROSION/EXTRUSION/PROTRUSION OF THE MESH); BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; THIGH PAIN; OTHER PAIN: BEARING DOWN PAIN; PAINFUL INTERCOURSE; INABILITY TO HAVE INTERCOURSE; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; DAMAGE; PSYCHIATRIC INJURY. NONSURGICAL TREATMENTS: ON (B)(6) 2009 THE PATIENT COMMENCED PSYCHOLOGICAL MEDICATION: PRISTIQ SR 50 MG, ANTI-DEPRESSANT TO DEAL WITH UNRESOLVABLE ISSUES AS A RESULT OF MESH/TAPE INJURIES AND TRAUMA. TREATMENT DURATION: 6.5 YEARS. ON (B)(6) 2010 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): HIPREX, TO INHIBIT BACTERIAL GROWTH IN BLADDER. TREATMENT DURATION: 12 MONTHS. DEVICE 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828484 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION 850-700

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention