BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 12930692 · Received December 4, 2021

    Report

    Report Number
    3005099803-2021-07244
    Event Type
    Injury
    Date Received
    December 4, 2021
    Date of Event
    June 15, 2010
    Report Date
    August 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729784784
    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

    ADDITIONAL INFORMATION: BLOCK A3 BLOCK B5: PROCEDURE NAMES FOR THE SECOND SOLYX IMPLANT. BLOCKS D4 AND H4 CORRECTION TO: BLOCKS A1: PATIENT IDENTIFIER AND B7 HAVE BEEN ADDED. BLOCK E1 (BELOW) BLOCK A1: MESHC-20210921-CD5CDCA8 BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2010, SECOND SOLYX IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: (B)(6). ADDITIONAL ATTORNEY FOR THE PATIENT: REBECCA JANCAUSKAS SHINE LAWYERS LEVEL 6, (B)(6). BLOCK H6: THE FOLLOWING PATIENT CODES CAPTURE THE REPORTABLE EVENTS BELOW: E2006 - EROSION/EXTRUSION E1405 - DYSPAREUNIA E2401 - "DAMAGE" E2330 - PAIN IMPACT CODE F12 HAS BEEN USED IN THE LIGHT OF THE PATIENT HAD FILED A LEGAL CLAIM FOR AN UNSPECIFIED PERSONAL INJURY RELATED TO THE DEVICE. IMPACT CODES F1905 AND F2303 CAPTURE THE REPORTABLE EVENTS OF DEVICE REVISION AND MEDICATIONS. CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. 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.

    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 1 OF 2 ***ADDITIONAL INFORMATION RECEIVED ON JULY 20, 2022/CORRECTION: NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES IMPLANTED INTO THE PATIENT. A SOLYX WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR VAGINAL REPAIR AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. A SECOND SOLYX DEVICE WAS IMPLANTED INTO THE PATIENT DURING A VAGINAL SACROCOLPOPEXY, CYSTOSCOPY, INSERTION OF SUPRAPUBIC CATHETER PROCEDURE PERFORMED ON (B)(6) 2010.

    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 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828479 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507001 0ML9102801 08714729784784

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention