Lynx™ System M0068503000Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 08714729718949), received between Dec 19, 2016 and Aug 28, 2026 — classified as 177 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 181 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Material Integrity Problem

  It was reported to Boston Scientific Corporation that Lynx Suprapubic Mid-Urethral Sling System was implanted into the patient during a procedure performed on (b)(6) 2024. The device subsequently malfunctioned and eroded into her bladder, resulting in substantial pain, nerve damage, tissue damage, and the need for ongoing medical care, including multiple corrective surgeries, such as removal of the mesh beginning on (b)(6) 2024.Following the procedure, the patient also experienced the following: emotional distress, physical disfigurement, and permanent injury.

  Patient problems: Deformity/ Disfigurement; Erosion; Nerve Damage; Pain; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 50507215 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH AND LYNX SYSTEM DEVICES WERE IMPLANTED IN THE PATIENT DURING ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH CYSTOSCOPY, SACROCOLPOPEXY, PERINEORRHAPHY, AND A TENSION-FREE MID-URETHRAL SLING; THERE WERE NO INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. FOLLOWING THE PROCEDURE, THE PATIENT HAD A URETHRAL MESH EROSION WITH SCARRING AND URETHRAL STRICTURE, WHICH PRESENTED AS DYSURIA, HEMATURIA, AND RECURRENT URINARY TRACT INFECTIONS. THE PATIENT SUBSEQUENTLY UNDERWENT A REMOVAL OR REVISION OF VAGINAL MESH, CYSTOSCOPY AND COMPLEX URETHROPLASTY ON (B)(6) 2025. THERE WAS NO BLADDER PERFORATION OR INTRAVESICAL MESH MIGRATION, ESTIMATED BLOOD LOSS WAS 400 ML, NO INTRAOPERATIVE COMPLICATIONS OCCURRED, THE PATIENT TOLERATED THE PROCEDURE WELL, AND POSTOPERATIVE STATUS INCLUDED AN INDWELLING 18F FOLEY CATHETER WITH PLANNED REMOVAL AFTER 14 DAYS AND ROUTINE FOLLOW-UP.

  Patient problems: Dysuria; Erosion; Hematuria; Scar Tissue; Urethral Stenosis/Stricture; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24337587 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2020. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24336888 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LYNX SYSTEM WAS IMPLANTED TO THE PATIENT ON (B)(6) 2018. SOMETIME AFTER IMPLANTATION, IN 2022, THE PATIENT PRESENTED WITH A FOUR-YEAR HISTORY OF RECURRENT URINARY TRACT INFECTIONS REQUIRING REPEATED ANTIBIOTIC TREATMENT, WITH EMERGING ANTIBIOTIC RESISTANCE, AS WELL AS STRESS URINARY INCONTINENCE, MORNING URGENCY, AND INCOMPLETE BLADDER EMPTYING. URODYNAMIC TESTING PERFORMED IN 2022 DEMONSTRATED SENSORY URGENCY WITH REDUCED FUNCTIONAL BLADDER CAPACITY AND MARGINALLY DYSFUNCTIONAL VOIDING, WITHOUT CONVINCING EVIDENCE OF OBSTRUCTION. THE PATIENT SUBSEQUENTLY UNDERWENT A 12-WEEK COURSE OF PERCUTANEOUS TIBIAL NERVE STIMULATION BUT REPORTED MINIMAL PERCEIVED BENEFIT. BY (B)(6) 2025, THE PATIENT'S URINARY TRACT INFECTIONS HAD RESOLVED; HOWEVER, HER PRIMARY ONGOING CONCERNS INCLUDED STRESS URINARY INCONTINENCE, POSTURAL INCONTINENCE, AND INTERMITTENT URGE-RELATED LEAKAGE. SHE HAS BEEN WAITING FOR FURTHER TESTING.

  Patient problems: Micturition Urgency; Unspecified Kidney or Urinary Problem; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24327043 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE LYNX DEVICE, THE PATIENT EXPERIENCED MULTIPLE INJURIES, INCLUDING MESH EXPOSURE, VAGINAL BLEEDING, DYSPAREUNIA, DECREASED AMBULATION, THE NEED FOR CATHETERIZATION AND SUTURE TRIMMING, ULTIMATELY REQUIRING MESH REMOVAL SURGERY ON (B)(6) 2024. AS A RESULT OF THE MESH, SHE HAS SUFFERED SIGNIFICANT PHYSICAL AND EMOTIONAL PAIN AND SUFFERING, FINANCIAL BURDENS, AND DISFIGUREMENT, AND MAY REQUIRE ADDITIONAL SURGERY AND LONG-TERM MEDICAL CARE, WITH CONTINUING PHYSICAL, MENTAL, AND ECONOMIC HARM.

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 22367202 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A LYNX SYSTEM DEVICE, AND SHE CLAIMED TO HAVE EXPERIENCED EXTREME PAIN, INFECTION OF HER INTERNAL BODILY TISSUE, URINARY PROBLEMS, AND OTHER INJURIES AS A RESULT OF THE IMPLANTATION. FURTHERMORE, THE PATIENT CLAIMS TO HAVE SUFFERED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AND HAS SUSTAINED PERMANENT INJURY. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH A RENAL STONE AND BLADDER MESH EROSION. SHE UNDERWENT RIGHT URETEROSCOPIC STONE EXTRACTION USING LASER AND BASKET, ALONG WITH VAGINAL EXCISION OF THE MESH. OPERATIVE FINDINGS INCLUDED A 1.4 CM RENAL PELVIC STONE, WHICH WAS SUCCESSFULLY REMOVED. THE STENT AND VAGINAL MESH WERE ALSO REMOVED. HOWEVER, CYSTOSCOPY REVEALED A REMAINING PORTION OF MESH WITHIN THE BLADDER. ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH A RIGHT RENAL STONE, BLADDER STONE, AND RECURRENT BLADDER MESH EROSION. SHE UNDERWENT RIGHT URETEROSCOPIC STONE EXTRACTION, CYSTOLITHOLAPAXY, ROBOTIC BLADDER MESH REMOVAL, AND RIGHT BURCH URETHROPEXY. OPERATIVE FINDINGS INCLUDED RENAL STONES THAT WERE LASERED AND EXTRACTED, BLADDER STONES TREATED WITH LASER, AND EXCISION OF MESH EROSIONS. A BILATERAL BURCH URETHROP

  Patient problems: Erosion; Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 22215809 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LYNX DEVICE IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING ABDOMINAL PAIN, BLADDER NECK OBSTRUCTION, MIXED INCONTINENCE AND MAJOR DEPRESSION. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. DUE TO BLADDER NECK OBSTRUCTION AND A HISTORY OF SUBURETHRAL SLING PLACEMENT, THE PATIENT UNDERWENT SLING REVISION ON (B)(6) 2022. AN INVERTED U-SHAPED VAGINAL INCISION WAS MADE TO ACCESS THE SURGICAL FIELD. THE URETHRAL COMPLEX WAS IDENTIFIED AND EXPOSED. INTRAOPERATIVELY, THE PREVIOUSLY PLACED SLING WAS FOUND TO BE PARTIALLY TRANSECTED, RESULTING IN KINKING OF THE BLADDER NECK. THE SLING WAS EXCISED BILATERALLY THROUGH THE RETROPUBIC SPACE, EFFECTIVELY RELEASING THE URETHRA. THE VAGINAL WALL WAS THEN CLOSED USING ABSORBABLE SUTURES. CYSTOSCOPY WAS PERFORMED VIA THE URETHRA, CONFIRMING NO EVIDENCE OF BLADDER OR URETHRAL INJURY. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH APPROPRIATE MEDICATIONS AND FOLLOW-UP INSTRUCTIONS.

  Patient problems: Abdominal Pain; Depression; Micturition Urgency; Obstruction/Occlusion; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 22114802 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LYNX SYSTEM DEVICE IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING URINARY OUTLET OBSTRUCTION AND ASSOCIATED PAIN AND SUFFERING. THE PATIENT ALSO UNDERWENT REVISION SURGERY TO REMOVE THE MESH PRODUCT. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES AS A RESULT OF THE DEVICE IMPLANTATION.

  Patient problems: Abscess; Atrophy; Erosion; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Pain; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 22008705 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LYNX SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING PELVIC, PERINEAL, AND LOW BACK PAIN, INFECTIONS, DYSPAREUNIA, FURTHER OR WORSENING URINARY PROBLEMS, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Dyspareunia; Hemorrhage/Blood Loss/Bleeding; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21886610 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A LYNX SYSTEM DEVICE WAS IMPLANTED DURING A SURGICAL PROCEDURE. FOLLOWING THE MESH IMPLANTATION, THE PATIENT EXPERIENCED COMPLICATIONS, INCLUDING EROSION OF THE MESH INTO SURROUNDING TISSUES AND ORGANS, FREQUENT URINARY TRACT INFECTIONS, AND PURULENT VAGINAL DISCHARGE. ADDITIONALLY, THE PATIENT REPORTED SYMPTOMS OF URINARY INCONTINENCE AND PELVIC PAIN. AS A RESULT, THE PATIENT UNDERWENT A PARTIAL PELVIC MESH EXCISION SURGERY ON (B)(6) 2022, TO ADDRESS THE ISSUES CAUSED BY THE MESH IMPLANTATION.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Chills; Deformity/ Disfigurement; Dehydration; Discomfort; Dysuria; Erosion; Fatigue; Headache; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Pain; Skin Inflammation/ Irritation; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21744339 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THIS LYNX SYSTEM EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Erosion; Insufficient Information; Micturition Urgency; Pain; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 21355881 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LYNX SYSTEM WAS IMPLANTED TO THE PATIENT. DURING THE SAME PROCEDURE, CYSTOSCOPY WAS ALSO PERFORMED WHICH REVEALED NORMAL APPEARING AND NO EVIDENCE OF TRAUMA TO THE BLADDER OR TO THE URETHRA. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH MESH EROSION AND PAIN IN THE BLADDER. SHE UNDERWENT ROBOTIC- ASSISTED REMOVAL OF SLING MESH FROM BLADDER MUCOSA AND MUSCULARIS WITH INTENTIONAL CYSTOTOMY AND REPAIR, VAGINAL MID-URETHRAL DISSECTION, AND CYSTOURETHROSCOPY. OPERATIVE FINDINGS REVEALED, WHEN CYSTOURETHROSCOPY WAS PERFORMED, TWO TO THREE CENTIMETERS OF WHITE SLING MESH WITH ENTRY AND EXIT POINT IN THE LEFT BLADDER WALL IN TRAJECTORY OF RETROPUBIC SLING TROCAR PLACEMENT WAS NOTED. NO BLADDER STONES SEEN AND THE BLADDER MUCOSA WAS NORMAL. NO OTHER MESH OR FOREIGN OBJECTS NOTED. ONE RIGHT AND ONE LEFT URETERAL ORIFICE IN THE NORMAL ANATOMIC POSITION. THE URETHRA WITH MESH EXPOSURE AND URETHROSCOPY WERE NORMAL. INTRAABDOMINAL SURVEY REVEALED FILMY ADHESIONS OF OMENTUM TO ABDOMINAL WALL AT SITE OF PRIOR MIDLINE INCISION AND RIGHT SIDEWALL OUT OF OPERATIVE FIELD AND NOT TAKEN DOWN, OTHERWISE INTRAABDOMINAL SURVEY WAS NORMAL. WHEN THE BLADDER WAS TAKEN DOWN, THE MESH WA

  Patient problems: Erosion; Pain

  MAUDE report 20698454 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT HAD BEEN IMPLANTED WITH A LYNX SYSTEM DEVICE, SHE EXPERIENCED RECURRENT URINARY TRACT INFECTIONS. SHE SUBSEQUENTLY UNDERWENT PERIURETHRAL REMOVAL OF THE MESH. DURING THE PROCEDURE, A CYSTOSCOPE WAS PLACED TO IDENTIFY THE PERIURETHRAL MESH. THE MESH WAS IDENTIFIED, DISSECTED, AND TRIMMED BY ABOUT 2 CM. TISSUE WAS SENT FOR PATHOLOGY. THE DEAD SPACE AROUND THE URETHRA WAS CLOSED WITH 3-0 VICRYL, AND THE SKIN WAS CLOSED WITH 2-0 VICRYL. FLOSEAL WAS USED FOR HEMOSTASIS. CYSTOSCOPY SHOWED INTACT UROTHELIUM. THE PATIENT TOLERATED THE PROCEDURE WELL AND REMAINED HEMODYNAMICALLY STABLE.

  Patient problems: Erosion; Pain; Urinary Tract Infection

  MAUDE report 20695742 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUBURETHRAL SLING PROCEDURE WHERE A LYNX SYSTEM WAS IMPLANTED. AFTER THE PROCEDURE, CYSTOSCOPY EVALUATION SHOWED NO TRAUMA TO THE BLADDER. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH EXTRUSION AND DYSPAREUNIA. SHE EXPERIENCED PAIN AND IRRITATION AT THE ANTERIOR VAGINAL WALL. CYSTOSCOPIC EXAM WAS NORMAL WITH NO URETHRAL OR BLADDER EROSION. PROPER RETRACTION WAS USED TO IDENTIFY THE MESH EXPOSURE AND CONFIRMED THAT THERE WAS NO OTHER MESH EXPOSURE OTHER THAN THE LEFT VAGINAL FORNIX LATERAL TO THE URETHRA WHERE THE LATERAL FLAP WOULD HAVE BEEN, WHICH WAS 5 MM BY 3 MM. THE MESH THAT WAS EMBEDDED INTO THE VAGINAL TISSUE WAS CUT AND WAS COPIOUSLY IRRIGATED. THE VAGINAL FLAPS WERE HEALTHY AND SUFFICIENT TO COVER THE DEFECT, AND NO MESH WAS AT THE EDGES OF THE FLAPS. THE FLAPS APPEARED HEALTHY. THE VAGINA WAS COPIOUSLY IRRIGATED ONCE AGAIN, AND THE CLOSED WOUND WAS HEMOSTATIC. SHE WAS TO USE TOPICAL VAGINAL ESTROGEN FOR 6 WEEKS AND FOLLOW-UP FOR AN EXAM IN TWO WEEKS.

  Patient problems: Dyspareunia; Erosion; Pain; Skin Inflammation/ Irritation

  MAUDE report 19819123 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO YEARS AFTER A LYNX SUPRAPUBIC SLING IMPLANT PROCEDURE, THE PATIENT STARTED TO EXPERIENCE BODY ACHES, INFLAMMATION, AND DRY EYES. THE PATIENT NOTED GOING THROUGH A LOT OF DOCTOR VISITS AND MEDICATION TAKING. ADDITIONALLY, THE PATIENT HAD BEEN DIAGNOSED WITH SJOGREN, AN AUTOIMMUNE DISEASE WHICH SHE SUSPECTED TO BE RELATED TO THE SLING BEING IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 19366808 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A LYNX SYSTEM WAS USED DURING A TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER THE TAPE WAS ATTACHED TO THE INTRODUCERS, WHILE PULLING THE INTRODUCER NEEDLES UP THROUGH THE ABDOMINAL INCISIONS, THE TAPE DETACHED ON BOTH SIDES BEFORE IT CLEARED THE ABDOMINAL SKIN. THERE WAS NO WAY TO REACH THE DETACHED END WHICH NECESSITATED REPEATING THE ENTIRE PROCESS OF PLACING THE TAPE. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED, SHOWING BOTH THE DELIVERY DEVICES AND THE MESH WITHIN THE PROTECTIVE SLEEVES. THE BLUE DILATORS WERE STILL ATTACHED TO THE INTRODUCERS, BUT BOTH OF THE DILATORS WERE COMPLETELY DETACHED FROM THE CLEAR PLASTIC SLEEVES. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579553 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED DURING A TOTAL VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMIES, SACROSPINOUS VAULT SUSPENSION, SUB URETHRAL PLACEMENT OF SLING WITH THE TOP-BOTTOM TECHNIQUE USING LYNX AND POSTERIOR COLPORRHAPHY PROCEDURE PERFORMED ON (B)(6), 2016, FOR THE TREATMENT OF COMPLETE PROCIDENTIA, UTEROVAGINAL PROLAPSE, CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. THE PATIENT WAS DIAGNOSED WITH URINARY RETENTION AFTER SLING WHICH WAS WORSENING OVER TIME. THE PATIENT THEN UNDERWENT VAGINAL SLING REMOVAL, CYSTOSCOPY AND URETHROLYSIS ON (B)(6), 2017. DURING PROCEDURE, IT WAS OBSERVED THAT THE PREVIOUS URETHRAL SLING WAS PALPATED. USING METZ SCISSORS, THIS WAS SEPARATED IN ITS ENTIRELY FROM URETHRA. IT WAS THEN INCISED AND A SEGMENT WAS REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS EXTUBATED AND TAKEN TO RECOVERY.

  Patient problems: Urinary Retention

  MAUDE report 18050350 ↗
• InjuryOct 5, 2023Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR AND POSTERIOR COLPORRHAPHY + SLING URETHROPEXY PROCEDURE PERFORMED ON (B)(6) 2004, FOR THE TREATMENT OF CYSTOCELE, RECTOCELE AND STRESS INCONTINENCE. EXAMINATION OF THE VAGINAL AREA REVEALED A CYSTOCELE AND RECTOCELE, AND THE VAGINAL VAULT WAS MILDLY PROLAPSED. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH INCOMPLETE BLADDER EMPTYING, RECURRENT UTI, HAD HISTORY OF SUB-URETHRAL MESH, URGE INCONTINENCE, AND DYSPAREUNIA AND UNDERWENT CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS AND LIMITED PELVIC EXAM UNDER ANESTHESIA. INTRAOPERATIVE FINDINGS INCLUDED INDURATION OF THE ANTERIOR VAGINAL WALL ALONG WITH EXPECTED COURSE OF A PALPABLE MESH SLING. THE SLING APPEARS TO BE PROXIMAL NEAR THE BLADDER NECK AND KINKING. THERE WAS NO EVIDENCE OF VAGINAL EXTRUSION. SHE HAD A GRADE 2 PLUS CYSTOCELE. IT WAS BELIEVED THAT THE SLING WAS OBSTRUCTING THE BLADDER NECK AND WAS LIKELY CAUSING SYMPTOMS OF INCOMPLETE EMPTYING, DYSPAREUNIA, AND OBSTRUCTION. THE MISPOSITIONED MESH APPEARED TO BE NOTED. SHE STILL HAD PERSISTENT STRESS INCONTINENCE. IT WAS RECOMMENDED TO REMOVE THE SLI

  Patient problems: Adhesion(s); Dyspareunia; Micturition Urgency; Obstruction/Occlusion; Prolapse; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 17882019 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A BOSTON SCIENTIFIC LYNX MID-URETHRAL SLING + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF MIXED INCONTINENCE. DURING THIS OPERATION, THE ANTERIOR VAGINAL WALL WAS SOMEWHAT ATROPHIC AND FELT SOMEWHAT SCARRED AND ADHERENT SUGGESTIVE OF MILD IDIOPATHIC FIBROSIS. LIDOCAINE WITH EPINEPHRINE WAS INJECTED AROUND THE URETHRA. THERE WERE NO COMPLICATIONS, AND THE PATIENT WAS IN STABLE CONDITION AT THE END. ON (B)(6) 2022, THE PATIENT UNDERWENT TRANSVAGINAL MESH EXCISION AND INTRADETRUSOR ONABOTULINUMTOXINA INJECTION PROCEDURE DUE TO VAGINAL MESH EXPOSURE AND OVERACTIVE BLADDER. EXAMINATION SHOWED A 1-1.5CM TRANSVERSE AREA OF A VAGINAL MESH EXPOSURE AT THE LEVEL OF THE MID URETHRA. THIS EXTENDED FROM JUST RIGHT OF THE MIDLINE TO SLIGHTLY LEFT OF THE MIDLINE AND REPRESENTED THE DISTAL EDGE OF THE MESH SLING. THE MESH ARMS WERE TRANSECTED AND SENT TO PATHOLOGY. INSPECTION OF THE WOUND BED DID NOT IDENTIFY ANY INJURY TO THE BLADDER OR URETHRA. BLADDER BOTOX INJECTION WAS THEN PERFORMED. A TOTAL OF 100 UNITS OF BOTOX DILUTED IN 10ML OF INJECTION GRADE SALINE WE

  Patient problems: Erosion; Micturition Urgency

  MAUDE report 17772097 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A CYSTOSCOPY WITH MODIFIED SPIRAL SLING PROCEDURE PERFORMED ON (B)(6), 2017, FOR THE TREATMENT OF STRESS INCONTINENCE. THERE WERE NO COMPLICATIONS NOTED AND THE PATIENT WAS BROUGHT TO THE PACU IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6), 2020, THE PATIENT PRESENTED FOR CYSTOSCOPY WITH REPAIR OF URETHRAL DIVERTICULUM AND PARTIAL EXCISION OF MESH SLING. THE INDICATION FOR THE PROCEDURE WAS DYSURIA. THE PATIENT WAS ADMITTED AND WAS BROUGHT TO THE OPERATIVE SUITE. CYSTOSCOPY PROCEDURE WAS PERFORMED AND FOUND NO FOCAL AREAS OF ERYTHEMA, PAPILLARY LESION OR BLADDER CALCULI. THE URETERAL ORIFICES WERE IN NORMAL POSITION. HOWEVER, WHEN THE URETHRA WAS INSPECTED USING THE 12-DEGREE LENS, THERE WERE INDENTATION AND MASS-EFFECT IN THE POSTERIOR BLADDER WALL BUT WITH NO DEFINITE DIVERTICULUM OR EROSION. BUT WHEN SWITCHED TO THE 70-DEGREE LENS, EVIDENCE OF A POSSIBLE DIVERTICULAR OPENING IN THE REGION OF THE MID URETHRA WAS OBSERVED. CYSTOSCOPE WAS REMOVED AND A FOLEY CATHETER WAS PLACED INTO THE BLADDER. A 1% LIDOCAINE WITH EPINEPH

  Patient problems: Dysuria; Erosion; Inflammation; Insufficient Information; Perforation

  MAUDE report 17548027 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LYNX SLING PROCEDURE PERFORMED ON (B)(6) 2006, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. PHYSICAL EXAM REVEALED MARKED BLADDER NECK HYPERMOBILITY WITH LEAKAGE, WITH REPETITIVE COUGHING. PATIENT NOTED THAT SHE DEVELOPED DYSURIA JUST PRIOR TO MENSTRUAL PERIOD AND FOLLOWING SEXUAL ACTIVITY. ON (B)(6) 2021, THE PATIENT UNDERWENT LYNX SLING REMOVAL, URETHRAL LYSIS, ANTERIOR COLPORRHAPHY, ABDOMINAL PARAVAGINAL AND REMOVAL OF ABDOMINAL MESH DUE TO VAGINAL PAIN, PELVIC PAIN, CHRONIC URINARY TRACT INFECTIONS, PAIN WITH COITUS, URINARY STRICTURE AND INFECTED SLING. THIS WAS A VERY DIFFICULT SURGERY DUE TO THE URETHRAL SCARRING AND INFECTED SLING. THE PREVIOUS LYNX SLING WAS IDENTIFIED TO BE INFECTED WITH A FOUL SMELL. THE MESH WAS INCISED IN THE MIDLINE AND DISSECTED THE LEFT AND RIGHT FREE. A URETHRAL LYSIS WAS PERFORMED WITH SHARP DISSECTION TO FURTHER FREE THE URETHRA AND SCAR TISSUE ON THE LEFT AND ON THE RIGHT. THE SLING ON THE LEFT AND RIGHT WERE FREED FROM THE UNDERLYING TISSUES AND BLADDER WALL AND DISSECTED LATERALLY INTO THE RETROP

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Hematuria; Pain; Prolapse; Scar Tissue; Stenosis; Unspecified Infection; Urinary Tract Infection

  MAUDE report 17547484 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED DURING A CYSTOSCOPY WITH THE INSERTION OF MID-URETHRAL RETROPUBIC SLING PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS INCONTINENCE. THROUGHOUT THE PROCEDURE, THERE WERE NO COMPLICATIONS. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17541585 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PLACEMENT OF LYNX URETHRAL SLING + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY AREA IN STABLE CONDITION. ON (B)(6) 2021, THE PATIENT HAD HER FIRST REVISION SURGERY DUE TO LEFT URETERAL CALCULUS WITH HYDRONEPHROSIS AND POSTOPERATIVELY, LEFT-SIDED URETERAL STONE HYDRONEPHROSIS AND EXPOSED URETHRAL MESH WITH URETERAL CALCIFICATION. AT THE LEVEL OF THE URETHRA, APPEARED TO BE A LARGE CALCIFICATION WHICH WAS INITIALLY THOUGHT AS A BLADDER STONE OR THE PASSED URETERAL STONE WASH IN THE URETHRA. HOWEVER, THIS WAS QUITE DENSE IN NATURE. THE LARGE CALCIFICATION WAS ATTEMPTED TO BE EXTRACTED FROM THE URETHRA BUT WAS UNSUCCESSFUL. IT WAS THEN FRAGMENTED INTO SMALLER PIECES USING A 365-HOLMIUM LASER FIBER AND WAS REMOVED COMPLETELY. THE RIGID URETEROSCOPE WAS ADVANCED INTO THE RENAL PELVIS, AND RETROGRADE PYELOGRAM WAS SHOT SHOWING VERY MILD HYDRONEPHROSIS. UPON FURTHER EXAMINATION OF THIS URETERAL CALCIFICATION, IT WAS DETERMINED THAT THIS WAS LIKELY THE E

  Patient problems: Calcium Deposits/Calcification; Erosion; Obstruction/Occlusion

  MAUDE report 17538457 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL ABDOMINAL HYSTERECTOMY WITH ABDOMINAL SACRAL COLPOPEXY + RECTOCELE REPAIR + LYNX SUB-URETHRAL SLING AND CYSTOSCOPY + EXCISION OF VAGINAL MESH EROSION (NON-BSC) + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010, DUE TO LARGE UTERINE PROLAPSE AND RECTOCELE AS WELL AS PERSISTENT STRESS INCONTINENCE. THE PATIENT HAD A TRANS-OBTURATOR SYNTHETIC MID-URETHRAL SLING AND PLACEMENT OF ANTERIOR PERIGEE IN 2006. DURING THE LYNX DEVICE PLACEMENT, THERE WAS A LARGE VAGINAL MESH EROSION EXTENDING HORIZONTALLY AT THE LEVEL OF THE BLADDER BASE. THIS WAS PRESUMED TO BE DUE TO ITS LOCATION TO REPRESENT THE MOST DISTAL PORTION OF THE PERIGEE DEVICE. IT WAS THEN UNDERMINED AND EXCISED. THE LYNX DEVICE WAS PLACED, AND CYSTOURETHROSCOPY CONFIRMED THERE WAS NO TROCAR INJURY. THERE WAS BILATERAL SPILL OF INDIGO CARMINE AND NO EVIDENCE OF INJURY TO THE BLADDER DURING THE ANTERIOR COLPORRHAPHY. ADDITIONALLY, AN INTEPRO AMS Y-MESH WAS ATTACHED TO THE ANTERIOR AND POSTERIOR VAGINA USING INTERRUPTED FIGURE-OF-8 SUTURES OF 2-0 PDS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 17478565 ↗
• InjuryAug 1, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL VAGINAL HYSTERECTOMY + TVT + ANTERIOR AND POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2007, FOR THE TREATMENT OF UTERINE PROLAPSE, CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2022, THE PATIENT HAD LYNX SLING REMOVAL, URETHRAL LYSIS, ANTERIOR COLPORRHAPHY, AND REMOVAL OF ABDOMINAL MESH DUE TO VAGINAL PAIN, PELVIC PAIN, LEFT GROIN PAIN, PAIN WITH COITUS, SUPRAPUBIC PAIN, AND URINARY STRICTURE. THIS WAS A VERY DIFFICULT SURGERY DUE TO THE SEVERE SCARRING FROM PREVIOUS SURGERY AS WELL AS THE RIGHT AND LEFT SLING ARMS BEING DEEP IN THE OBTURATOR MUSCLES. A URETHRAL LYSIS WAS PERFORMED WITH SHARP DISSECTION TO FURTHER FREE THE URETHRA AND SCAR TISSUE. THE ENTIRE SLING ARM WAS HANDED OFF THE OPERATIVE FIELD.

  Patient problems: Obstruction/Occlusion; Pain; Scar Tissue; Stenosis

  MAUDE report 17434240 ↗