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

Model Number M0068503000

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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Micturition Urgency (1871); Itching Sensation (1943); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Urinary Incontinence (4572)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation: (b)(6) law firm.(b)(6).The implanting physician is: dr.(b)(6).(b)(6).The physician who performed the revision is: dr.(b)(6).(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e1309 - incomplete bladder emptying e1310 - recurring urinary tract infection the following imdrf impact code capture the reportable event of: f1905 - a small segment of mesh was excised.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic synthetic mid-urethral sling placement and cystoscopy procedure performed on (b)(6) 2017 for the treatment of stress urinary incontinence.There were no complications noted during the surgery.Cystoscopy also revealed no lesions in the bladder, bladder neck, or urethra.On (b)(6) 2018, however, the patient underwent a transvaginal sling incision and cystoscopy procedure to address incomplete bladder emptying and recurring urinary tract infections.The sling was found to be in the usual orthotopic mid-urethral region, with no obvious signs of excessive stress.Additionally, a small section of the mesh was removed and sent for gross pathologic examination.Furthermore, cystoscopy was also conducted only to confirm that there were no other abnormalities or foreign bodies noted throughout the bladder, bladder neck, or urethra, and the patient was transferred to the recovery room in stable condition.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic synthetic mid-urethral sling placement and cystoscopy procedure performed on (b)(6) 2017 for the treatment of stress urinary incontinence.There were no complications noted during the surgery.Cystoscopy also revealed no lesions in the bladder, bladder neck, or urethra.On (b)(6) 2018, however, the patient underwent a transvaginal sling incision and cystoscopy procedure to address incomplete bladder emptying and recurring urinary tract infections.The sling was found to be in the usual orthotopic mid-urethral region, with no obvious signs of excessive stress.Additionally, a small section of the mesh was removed and sent for gross pathologic examination.Furthermore, cystoscopy was also conducted only to confirm that there were no other abnormalities or foreign bodies noted throughout the bladder, bladder neck, or urethra, and the patient was transferred to the recovery room in stable condition.***additional information was received on june 21, 2023*** on (b)(6) 2017, the patient presents to the emergency department with a complaint of having multiple symptoms after a recent bladder sling procedure.The patient recognizes itching inside of her vagina as well as what she describes to be pressure in the same area.She believes that she has a vaginal discharge with a slight odor.Her urine appears cloudy, and she has left flank pain.She does not report a clinical fever.No chest pain or shortness of breath.No definitive aggravating or alleviating factors.She does not give a pain scale.She denies any relevant family history.However, studies show evidence of a urinary tract infection but a low white blood cell count.Human chorionic gonadotropin (hcg) is negative.Otherwise, no significant laboratory findings.The doctor considered various possibilities, including surgical or acute abdomen and pyelonephritis, as they evaluated the patient.However, the patient did not exhibit any septic or toxic symptoms, and there was no evidence of focal deficits or weakness.To treat the patient, they administered iv levaquin and contacted the implanting facility to discuss the lab results.The physicians initially suspected pelvic inflammatory disease, but after further evaluation, they concluded it was unlikely.The patient received treatment with levaquin, flagyl, and rocephin and is now stable and ready for discharge.Although there was evidence of a urinary tract infection and bacterial vaginosis, there was no indication of pyelonephritis, and the patient's white blood cell count was not elevated.The patient and their family were informed and updated throughout the process.The patient was relieved and comfortable at the time of discharge, having received an additional dose of pain medication.Review of systems: neuro: the patient reports feeling sensations in the affected area and beyond.The patient's cranial nerves ii through xii appear to be functioning normally, as well as the cerebella.No major sensory or motor deficits have been identified.Gastrointestinal: the patient's abdomen is soft and non-tender, with no palpable or pulsatile masses and no audible bruits.Organomegaly is not present.Positive bowel sounds are present in all areas, with no rebound tenderness, rigidity, or guarding.Mcburney's point does not elicit any pain, and murphy's sign is negative.Scarring from previous surgical procedures is visible.Genitourinary: she has vague left sided cva tenderness, but there is none on the right, and she has suprapubic pain.Healing surgical wounds at the suprapubic area bilaterally.No palpable or visible evidence of abscess.On (b)(6) 2017, a patient sought medical attention at the emergency department.The chief complaint was lower abdominal pain, which had been ongoing for the past three days.The patient reported no fevers or chills, nor had she experienced any bright red blood per rectum or diarrhea.Vaginal bleeding or discharge was also not present.The patient expressed concern about a possible urinary tract infection.The pain was classified as moderate in intensity, with no aggravating or relieving factors.Moreover, the pain has been constant for the past three days.The context of the patient's condition involved the bladder mesh.Furthermore, the patient presents to the clinic for stress incontinence and recurrent urinary tract infection on (b)(6) 2018.She was treated with keflex and discharged.Currently on keflex day 3.According to the patient, it started with back pain, urgency, frequency, nausea, and lower abdominal pain on (b)(6) 2018.Reportedly, the patient had multiple failed medications for symptoms: myrbetriq, vesicare, and oxybutynin.Review of systems: genitourinary: positive for urgency (most of the time).Negative for dysuria, flank pain, frequency, and hematuria (with infections).

Manufacturer Narrative

Block h2: additional information: blocks a6 (race), b5 (event description) and b7 (other relevant history) has been updated based on the additional information received on june 21, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of july 21, 2017, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation: (b)(4).The implanting physician is: (b)(6).The physician who performed the revision is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e1309 - incomplete bladder emptying.E1310 - recurring urinary tract infection.E1901 - bacterial vaginosis.E2330 - left flank pain.E2330 - vaginal discharge with a slight odor.The following imdrf impact code capture the reportable event of: f1905 - a small segment of mesh was excised.F2303 - patient was given levaquin, flagyl and rocephin.F0101 - multiple failed medications.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16918650
• MDR Text Key: 315080939
• Report Number: 3005099803-2023-02564
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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
• Device Expiration Date: 08/11/2019
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0000039735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White