MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Hematuria (2558); Dyspareunia (4505)

Event Date 08/16/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during lynx suburethral sling placement and cystoscopy procedure performed on (b)(6) 2010, for the treatment of stress incontinence with urethral hypermobility.During the procedure, the cystoscopy revealed no inadvertent trocar injury, and the patient tolerated the procedure well.She was then transported to the recovery room and was in stable condition.On (b)(6) 2010, a patient came to the clinic complaining of persistent right flank pain after surgery.She also reported reduced urination output and underwent an x-ray which showed non-specific dilation in the right ureter.The doctor recommended a ct scan; she has a foley leg bag in place.The patient denied experiencing fevers, chills, sweats, shortness of breath, nausea, vomiting, and diarrhea.However, she admitted to experiencing abdominal pain and hematuria but denied dysuria and frequency.It's worth noting that she had a hysterectomy in 2008, and her last menstruation was before the operation.She continues to experience flank pain.During the physical examination, her abdomen was soft, tender in the suprapubic region, and nondistended.She had normal bowel sounds and no masses, however, she had right flank tenderness.The patient was alert and oriented.The patient was also given iv fluids, zofran, and morphine while she was in the emergency department.According to reports, the patient has developed trouble voiding.It is hard for her to start her urine stream.She has a constant feeling like she has to go.She, at times, actually has to push down with her hands on her abdomen to start her urine stream.She has also been experiencing frequent urinary tract infections.Her last one was two months ago.She has complaints of painful sexual intercourse.She has an achy, pretty constant lower abdominal discomfort that she does not call pain, just discomfort.Does not rate on the pain scale.She has increased pressure when voiding and feels like her bladder will fall out, which is relieved after voiding.She denies any gross hematuria currently.No dysuria, nausea, vomiting, or diarrhea.Her appetite has been fair.Her weight is stable.She has no complaints of chest pain, lower extremity swelling, shortness of breath, cough, wheezing, fever, or chills.Her functional status is moderate.She usually is active.She can climb stairs without chest pain or shortness of breath.Moreover, the patient returned to the clinic on (b)(6) 2014, requesting the removal of her sling.On the same date, the takedown of a synthetic mid-urethral sling and cystoscopy was performed.During the cystoscopy, it was confirmed that there was no inadvertent injury to the bladder.There was no inadvertent injury to the urethra.A bilateral spill of indigo carmine was noted as the patient had a prior right ureteral reimplantation.The patient tolerated the procedure well and was transferred to recovery in stable condition.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2010, was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting and explanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2330 - has been used to capture the reportable event of right flank pain.E1309 - has been used to capture the reportable event of patient having trouble voiding.E1310 - has been used to capture the reportable event of frequent urinary tract infections.E1405 - has been used to capture the reportable event of painful sexual intercourse.The following imdrf impact code capture the reportable event of: f1903 - has been used to capture the reported event of takedown of a synthetic mid-urethral sling.F2303 - has been used to capture the reported event of medication given to the patient to alleviate postoperative complications.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17358967
• MDR Text Key: 319386044
• Report Number: 3005099803-2023-03686
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Race: White