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

BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068503000

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Liver Damage/Dysfunction (1954); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Constipation (3274); Movement Disorder (4412); Suicidal Ideation (4429); Unspecified Mental, Emotional or Behavioural Problem (4430); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 02/07/2018

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.This event was reported by the patient's legal representation.The device was implanted at: (b)(6).(b)(4).The complainant indicated that the device is implanted and is not expected to be returned for evaluation; 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.

Event Description

Manufacturer Narrative

Additional information: blocks a2, a6, b2, b3, b5, b7, d6b, e1, e4, g2, h6 patient and impact codes.Implanting surgeon: dr.(b)(6).(b)(6) hospital.Sling removal surgeon: dr.(b)(6).(b)(6) hospital.Block b3 date of event: the exact event onset date is unknown.The provided event date, march 15, 2018, was chosen as a best estimate based on the date when patient first sought consult post procedure due to persistent pain.Block h6: patient codes e1310, e2326, e2330, e1002, e1405, e1906 capture the reportable events of recurrent utis, pelvic pain, dyspareunia, abdominal pain, inflammation, infection (yeast infection).Impact codes f1901, f1903, e2303, f2203, f18 capture the reportable events of additional surgery/sling removal and medications, imaging and physical therapy required.

Event Description

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date, march 15, 2018, was chosen as a best estimate based on the date when patient first sought consult post procedure due to persistent pain.Block e1: implanting surgeon: dr.(b)(6) (b)(6)hospital, oklahoma city, ok sling removal surgeon: dr.(b)(6) (b)(6)hospital st.Louis.Block h6: patient codes e1310, e2326, e2330, e1002, e1405, e1906 capture the reportable events of recurrent utis, pelvic pain, dyspareunia, abdominal pain, inflammation, infection (yeast infection).Impact codes f1901, f1903, e2303, f2203, f18 capture the reportable events of additional surgery/sling removal and medications, imaging and physical therapy required.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on january 24, 2023.Block h6: patient code e1302 captures the reportable event of gross hematuria.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a boston scientific lynx suprapubic mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.--- additional information received on (b)(6) 2022 --- (b)(6) 2018 the device, lynx suprapubic mid-urethral sling system, was implanted during a total robotic hysterectomy with bilateral oophorectomy, sling with cystoscopy procedure for the treatment of stress incontinence and pelvic pain.No complications were reported, and the patient was taken to recovery in stable condition.(b)(6) 2018 the patient presented with elevated blood pressure, stress reaction and social anxiety, insomnia and persistent pelvic pain.She reported she had been having persistent pain since her surgery two months ago.She had been taking percocet about every day to cope with the pain and that she cannot sleep without taking ambien.(b)(6) 2018 the patient reported ongoing concerns of constipation and bloating pain which have been present for several months since having her surgery, and the severity has been moderate and severe.She also reported painful urination and painful intercourse.She reported seven days without having a bowel movement and had tried stool softener and fiber.She was prescribed linzess and given trulance samples.She was also advised to consider miralax prior to starting linzess.The physician suspects multifactorial constipation due to postoperative changes and narcotic use.(b)(6) 2018 she presented with same complaints of dyspareunia and constipation.The dyspareunia was described as experienced stabbing pain at urethra during intercourse followed by 1-2 days of waves of aching, cramping, spasmic pain thereafter.She had been taking tylenol and percocet 1-2x a week when the pain was worst and experienced some relief.She also stated she saw a gi physician and was prescribed miralax 2 packs bid and linzess and that she had experienced some small volume liquid stool since, but not full relief.She underwent a complex uroflowmetry procedure.Reportedly, the patient had been having utis after coitus and would take macrobid after coitus.Since the sling surgery she had had 4-5 utis.(b)(6) 2018 the patient underwent lynx sling mesh removal, urethrolysis with anterior colporrhaphy, abdominal and vaginal paravaginal defect repair procedure for the treatment of vaginal pain, pain with coitus and abdominal pain.Postoperatively, a diagnosis of urinary stricture was also made.According to the surgeon, it was a very difficult surgery due to the severe urethral scarring from previous surgery as well as the right sling arm that was twisted and also due to being scarred to the pubic bone.The procedure was completed successfully without complications and the entire lynx sling was removed.Pathology noted fibroadipose tissue with embedded surgical material and chronic inflammation.(b)(6) 2018 the patient requested a referral to an endocrinologist.She is concerned about her hormones being "off", low libido, and difficulty sleeping.(b)(6) 2018 she reported having spasms in her urethra.(b)(6) 2018 the patient complained of a possible yeast infection, noted cottage cheese discharge and pain.She was prescribed diflucan 150mg tab.(b)(6) 2018 patient called and reported having a really bad uti.(b)(6) 2018 the patient sought referral to physical therapy for evaluation and treatment of nocturia, pelvic pain and urethral pain.Chief complaints include urinary incontinence, pain dyspareunia, urethral pain, pelvic floor spasms and splayed urine stream.She started on vaginal suppository (flurbiprofen 100mg/gabapentin 30mg/baclofen 20mg/diazepam 5mg) and stated that she had burning on her vulva.Per assessment, the patient would require skilled physical therapy services to address the problems identified, and to achieve individualized patient goals.Recommendations included skilled intervention to decrease pain, improve function, increase strength and educate patient.Treatment to include: 1.Myofascial release to affected muscles 2.Intravaginal trigger point release 3.Connective tissue release to restricted areas 4.Stretching exercises with hep (b)(6) 2018 the patient reported overall decrease in pelvic floor spasms with decreased need for suppositories since starting physical therapy.She continued to complain of pain with intercourse and post-coital pain.(b)(6) 2019 the patient reported having a "sweet smell" urine for several months that she's never had before and was concerned she might have diabetes mellitus.She also reported elevated bp in the afternoon up to the 150/90 range.(b)(6) 2019 the patient was seen due to a reducible hernia in the left inguinal region, which was suspected to be a regular inguinal hernia, but noted to be difficult to tell with her previous surgeries.She was prescribed lorazepam to use on an as-need basis for her anxiety.She reports that she was seen in the emergency room for lower abdominal pain and had a ct scan of the abdomen and pelvis which was negative except for fatty liver.(b)(6) 2019 the patient sought a second opinion regarding her complaint of a left inguinal hernia.She reported that she had cutaneous numbness in her suprapubic region.She stated that she has new onset bulging in the suprapubic region as well.She is unsure if this is an incisional hernia from mesh removal surgery or new onset hernia.(b)(6) 2019 the patient sought consult regarding her left inguinal hernia and wanted a surgery done without mesh.(b)(6) 2019 the patient presented for frequent urinary tract infections since the surgery in (b)(6) 2018.She would have uti at least every month and symptoms would include bladder pain, dysuria, urgency, frequency.The assessment included bladder pain related to either recurrent uti vs chronic cystitis for which a urinalysis was submitted; possible vaginitis for which a women's health panel was collected; pelvic pain and sui for which she was referred to physical therapy; and atrophy for which she was provided osphena samples.(b)(6) 2019 the patient sought referral to physical therapy.She reports that she had mesh removed due to severe pain and inability to void since mesh removal she had been diagnosed as having pelvic pain and described her goals for therapy as restoring the ability to complete daily routines by reducing pelvic pain.Recommendation: patient will be seen for therapy as described as follows: 8 visits over a 12-week plan of care.Medical diagnoses: 1.Unspecified dyspareunia 2.Pelvic and perineal pain 3.Other chronic pain treating diagnoses: 1.Low back pain 2.Abnormal posture 3.Dysuria 4.Other lack of coordination 5.Frequency of micturition (b)(6) , 2019 the patient presented again for recurrent utis, dyspareunia and complications of mesh placement s/p removal.She said she had been to see three specialists and she had multiple tests and multiple treatment recommendations.There may be an association of urinary tract infections with sexual intercourse.She was diagnosed with extended-spectrum beta-lactamases (esbl) and was treated with invanz intravenously for 7 days.(b)(6) 2020 the patient complained of pelvic bladder pain and would like urine sent off for culture.(b)(6) 2020 the patient requested pain pill prescription to have on hand when she was experiencing pain.She also had a urinalysis performed with negative results.She was prescribed percocet 7.5mg-325mg tab q6 prn, trimethoprim 100mg tab q hs, zofran 4mg tab q6 prn, and a refill of myrbetriq 25mg tablet er.(b)(6) 2020 the patient noted some dysuria and wanted to have urine sample checked.She underwent a bilateral nerve block with a total of 15cc of 0.5% marcaine, with no complications.She tolerated the procedure well.The impression was that the patient has a rather complex case with more than 1 potential pain generator.She certainly appeared to have evidence of ilioinguinal neuralgia left greater than right, significant pain associated with periurethral scarring right greater than left, and an area of localized provoked vulvodynia in the posterior fourchette of the vagina.Her findings were not terribly significant for pudendal neuralgia although she did have some potential symptoms consistent with that.She also did not appear to have classic symptoms or findings for obturator neuralgia.The patient was to report the results of the nerve block over the next 1-2 days.Assuming she did have significant albeit temporary pain relief she would be a candidate for bilateral ilioinguinal/iliohypogastric neurectomy.She also could be a candidate for release of periurethral scar tissue and a partial vestibulectomy with vaginal advancement.(b)(6) 2021 the patient underwent cystocele repair, urethral dilation and incision of urethral polyp procedure to treat a midline cystocele.She tolerated procedure well and taken to recovery in stable condition.***additional information received on january 24, 2023*** (b)(6) 2021 the patient was seen and examined for follow up due to cystocele, and urethral polyps.The patient reported to have genital infections the previous week.The patient stated gross hematuria which had not resolved.The patient reported painful intercourse and frequent urinary tract infections (utis) post coital.The patient wanted to discuss options to relieve pain and prevent infections.The patient has been previously diagnosed with urethral polyps and felt these may be contributing to her symptoms.Patient would like to discuss repeating pelvic floor pt.She was also diagnosed with dyssynergic defecation.The patient also reported dribbling following her bladder lift and would like to have a pelvic examination.(b)(6) 2021 the patient reported to have pelvic pain.The pain was on both sides.She has not had this kind of pain before.The pain was not related to her menstrual period.She described the pain as sharp.(b)(6) 2021 the patient reported to have chronic cystitis and cystocele.The patient's symptoms have gotten worse over the last year.The patient also reported pelvic pain.She was having problems with urinary control or incontinence.The patient wore protective pads.The patient was also seen and examined for a three-month post follow up for cysto retrograde pyelogram; urethral dilation with possible fulguration of polyps.The patient reported fatigue and weight gain.The patient also reported feeling tired/sluggish and she was either too hot or too cold.She also reported constipation and indigestion/heartburn.She also reported persistent itch.As part of the plan for the patient, the physician discussed the following: 1.Spraying when voiding, scar tissue from previous sling removal versus recurrent polyps.The patient may need dilation in the office.2.Pelvic pain might be chronic in nature from complications of sling.She has been told by another physician that pudendal nerve block may help and will refer the patient.3.Dyspareunia - she has seen her gyne for this.The physician's exam was relatively normal but with some discomfort under urethra.The rest of the vaginal exam did not elicit severe pain.The patient will be referred for pelvic floor pt.***additional information received on july 12, 2023*** on (b)(6) 2018, the patient was seen and examined for a complaint regarding sling.The patient was experiencing some pain in anus, poking pain in the urethra and some pain at the end of urination.She also reported pain in the posterior vagina when sexually aroused.In the physician's assessment, the patient has urinary stress incontinence, the patient was also noted to be anxious about continued pelvic pain.The physician explained that the healing process still have a way to go after only a month from hysterectomy.The patient was instructed to follow up as needed.On (b)(6) 2018, the patient called via telephone stating that she was having back pain and stabbing pain in her urethra.The patient felt like her mesh was too tight.The patient went to another healthcare facility in guthrie due to urinary tract infection (uti) and was prescribed rocephin and cephalexin.The patient was instructed to go to the clinic to have a urine culture and bladder scan.The patient felt like she was having difficulty urinating and had to think through the urination process.She noted that her urine flow was worse this day.The patient was scheduled for an appointment.On (b)(6) 2018, the patient called requesting an immediate appointment regarding her recent sling procedure.The patient stated her husband can feel sling during intercourse.The patient had an exam on (b)(6) 2018, and the physician noted that the sling was "doing okay." during the discussion, the patient's hysterectomy that was also performed during the sling placement was also brought up.The patient was upset that the medical assistant was telling her that it was not her sling.The medical assistant explained that she was not suggesting that but only informed the patient regarding the exam results performed on (b)(6) 2018.The patient was upset and was going to hang up.The patient called the physician later that day.The patient was complaining about pain on intercourse and her husband feeling a stabbing feeling.In the physician's assessment, it was too soon for the patient to be having intercourse, given that her surgery was five weeks ago.The patient was instructed not to have intercourse for six to eight weeks.The physician stated that it was a 1% chance the patient was experiencing problems from the mesh.The patient was continuing to complain about pain upon urination.The patient states it felt like a dried tampon being removed upon urination.Appointment was scheduled with the patient to discuss further with the physician.On (b)(6) 2018, the patient was seen and examined for complaints of painful urination.The patient still had a slight vaginal discharge.Lingering problem was her pelvic pain.The pain was described as electric, shooting, vaginal, anal, lower back and suprapubic.The pain was worse after intercourse or foreplay.The husband also felt irregularity in the vagina like sling erosion.In the physician's assessment, the patient's persistent pain did not seem to be related to the sling, rather it was very similar to the pain description she's had over the last two years pre-op.The patient inquired about removing the sling.The physician suggested to give it another three months, but the patient insisted to have the sling removed.Although the physician was worried her pain will be unaffected.The patient was prescribed with tramadol and gabapentin.On (b)(6) 2020, the patient mentioned the plastic mesh surgery affected her pelvis and back area.The patient "lives in a lot of pain." this has affected her personal life.She had to plan intercourse with her husband.She can't ride a bike, stand for five minutes, walk or ski.On (b)(6) 2020, the patient had suicidal ideations.The patient stated that this was due to an "accumulation of things and physical illness." her pelvic mesh pain had spread to her hip and back.The patient stated that she feared her husband would leave her.The patient felt alone and was afraid of living in poverty, alone and helpless.On (b)(6) 2021, the patient's urinary tract infections have occurred frequently and the medications to treat them made her feel drowsy.On (b)(6)2021, the patient said in a session that the complications from her mesh surgery may have contributed to liver disease.It had all occurred since she had the pelvic mesh surgery.The patient reported that oil and gas products were used to make the pelvic mesh.She believed that her health has diminished because of the mesh.The teeth of the mesh went into her bladder (urethra).The mesh had been in situ for four months at this point.A specialist in st, louis removed 15 inches of the mesh by surgery.On (b)(6) 2021, the patient had physical therapy.The patient was tested for further problems regarding mesh remnants.The patient felt she was still voiding particle matter.The patient had considered pain after any vaginal treatment, so the patient did not attempt this on this day due to her testing on friday.In the therapist's assessment, the patient's progress was slowed.They will wait for the patient's testing and further recommendations for care.As for the patient's urogenital pain and urogenital pelvic floor emg, the patient reported a reduction in symptoms and improvement in function of more than 90% since initiating therapy.Achieving the patient's goals with continued therapy was expected.The therapist recommended to hold on further treatment until the patient's test results are received.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date, march 15, 2018, was chosen as a best estimate based on the date when patient first sought consult post procedure due to persistent pain.Block e1: implanting surgeon: dr.(b)(6).Sling removal surgeon: dr.(b)(6).Block h6: patient codes e1310, e2326, e2330, e1002, e1405, e1906 capture the reportable events of recurrent utis, pelvic pain, dyspareunia, abdominal pain, inflammation, infection (yeast infection).Impact codes f1901, f1903, e2303, f2203, f18 capture the reportable events of additional surgery/sling removal and medications, imaging and physical therapy required.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on january 24, 2023.Block h6: patient code e1302 captures the reportable event of gross hematuria.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.Block h11: block b3 (date of event) has been corrected.Blocks b5, h6 and h10 have been updated based on the additional information received on july 12, 2023.Block b3 date of event (corrected based on the additional information): the exact event onset date is unknown.The provided event date, february 7, 2018, was chosen as a best estimate based on the date when patient first sought consult post procedure due to persistent pain.Block h6 (additional h6 codes): patient code e1309 captures the reportable event of urinary retention.Patient code e2006 captures the reportable event of extrusion.Patient code e0206 captures the reportable event of unspecified mental, emotional, or behavioural problem.Patient code e0205 captures the reportable event of suicidal ideation.Patient code e1104 captures the reportable event of liver damage.Patient code e0122 captures the reportable event of movement disorder.Patient code e2401 captures the reportable event of injury not otherwise specified.

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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

10028696

MDR Text Key

190001231

Report Number

3005099803-2020-01807

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718949

UDI-Public

08714729718949

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K020110

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

05/06/2020

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

01/19/2020

Device Model Number

M0068503000

Device Catalogue Number

850-300

Device Lot Number

0000053678

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

07/12/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

01/19/2017

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

48 YR

Patient Sex

Female

Patient Race

White

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

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