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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068503000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erosion (1750); Bruise/Contusion (1754); Diarrhea (1811); Fatigue (1849); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Anxiety (2328); Numbness (2415); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 08/21/2019 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.This event was reported by the patient's legal representative.The implant healthcare facility is: (b)(6).Serious injury has been used in the light of this patient had filed a legal claim for unspecified personal injury related to the device.The complaint device 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.
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Manufacturer Narrative
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Blocks a2, b5 (event description), e1 (surgeon and healthcare facility), and h6 (patient and impact codes) have been updated based on the additional information received on september 20, 2022.Block h11: block b2 (outcomes attrib to adv event) has been updated.Block b3 date of event: date of event was approximated to (b)(6) 2019, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon and healthcare facility are: dr.(b)(6) (b)(6) hospital (b)(6) the revision surgeon and healthcare facility are: dr.(b)(6) (b)(6) center (b)(6) block h6: patient codes e2006 and e2330 capture the reportable events of erosion (graft extrusion) and pain (vaginal pain, pelvic pain), respectively.Impact code f1905 capture the reportable event of device revision or replacement (excision of pubovaginal sling graft and vaginal wound closure).
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Event Description
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It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted during a pubovaginal sling (pvs) with anterior repair procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence and cystocele.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient returned for the second post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on (b)(6) 2019.The patient reported vaginal pain, pelvic pain, and vaginal discharge that developed 6 weeks ago.The pelvic pain was described as mild in severity, with a score of 5.The vaginal discharge began 6 weeks ago and was described as clear, white, and foul-smelling.The patient also complained of burning/dysuria.Exam revealed yellow-colored vaginal discharge and the presence of sutures.The incision sites were healing well.Silver nitrate was applied to the vaginal cuff.A cbc was normal, and urinalysis was negative.Ultrasound and follow-up with the surgeon were planned.On (b)(6) 2019, the patient underwent an excision of the pubovaginal sling graft and vaginal wound closure due to graft extrusion.During the procedure, a foley catheter was placed for gravity drainage.The above-mentioned graft extrusion is approximately 0.5cm in size exposed.The graft was carefully and bluntly manipulated to free the graft bilaterally after incising the vaginal mucosa vertically and freeing the vaginal mucosa bilaterally as far back as the endopelvic fascia.The graft was excised on both sides and discarded.The vaginal wall was then closed without tension with a 2-0 vicryl running suture.It should be noted that a copious amount of antibiotic irrigation was utilized throughout the case.Vaginal packing was placed, and the foley was left to gravity drainage.She tolerated the procedure well, with no complications.She returned to recovery in stable condition.On (b)(6) 2019, the patient returned for the 5th post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on (b)(6) 2019.A week ago, the patient had sling repair erosion.The patient reported pelvic pain that developed 3 weeks ago, and it was described as moderate in severity.Additionally, the patient had a history of ovarian cysts.Pelvic ultrasound revealed a right ovarian cyst.
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Manufacturer Narrative
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Blocks a2, b5 (event description), e1 (surgeon and healthcare facility), and h6 (patient and impact codes) have been updated based on the additional information received on september 20, 2022.Block b3 date of event: date of event was approximated to august 21, 2019, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon and healthcare facility are: (b)(6).The revision surgeon and healthcare facility are: (b)(6).Block h6: patient codes e2006 and e2330 capture the reportable events of erosion (graft extrusion) and pain (vaginal pain, pelvic pain), respectively.Impact code f1905 capture the reportable event of device revision or replacement (excision of pubovaginal sling graft and vaginal wound closure).Block h11: blocks a4, b5, b7, h6, and h10 have been updated based on the additional information received on november 7, 2022.Block h6: patient code e1405 captures the reportable event of pain during intercourse.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted during a pubovaginal sling (pvs) with anterior repair procedure performed on august 21, 2019, for the treatment of stress urinary incontinence and cystocele.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient returned for the second post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on august 21, 2019.The patient reported vaginal pain, pelvic pain, and vaginal discharge that developed 6 weeks ago.The pelvic pain was described as mild in severity, with a score of 5.The vaginal discharge began 6 weeks ago and was described as clear, white, and foul-smelling.The patient also complained of burning/dysuria.Exam revealed yellow-colored vaginal discharge and the presence of sutures.The incision sites were healing well.Silver nitrate was applied to the vaginal cuff.A cbc was normal, and urinalysis was negative.Ultrasound and follow-up with the surgeon were planned.On (b)(6) 2019, the patient underwent an excision of the pubovaginal sling graft and vaginal wound closure due to graft extrusion.During the procedure, a foley catheter was placed for gravity drainage.The above-mentioned graft extrusion is approximately 0.5cm in size exposed.The graft was carefully and bluntly manipulated to free the graft bilaterally after incising the vaginal mucosa vertically and freeing the vaginal mucosa bilaterally as far back as the endopelvic fascia.The graft was excised on both sides and discarded.The vaginal wall was then closed without tension with a 2-0 vicryl running suture.It should be noted that a copious amount of antibiotic irrigation was utilized throughout the case.Vaginal packing was placed, and the foley was left to gravity drainage.She tolerated the procedure well, with no complications.She returned to recovery in stable condition.On (b)(6) 2019, the patient returned for the 5th post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on august 21, 2019.A week ago, the patient had sling repair erosion.The patient reported pelvic pain that developed 3 weeks ago, and it was described as moderate in severity.Additionally, the patient had a history of ovarian cysts.Pelvic ultrasound revealed a right ovarian cyst.***additional information received on november 7, 2022*** on (b)(6) 2021, the patient was seen and examined via video.The patient had no chief complaints for this encounter.The patient started pt for her back pain.The patient was reportedly going to the gym.Sometime in march, the patient injured her right knee.Pt looked at and stated it was acl.She reinjured the day after last appointment.She stated she heard loud pop.The patient also reported that her back was still painful.In (b)(6) 2019, she had hysterectomy and bladder lift performed.At that time, a mesh was placed.In (b)(6) 2019, a second surgery due to mesh erosion was performed.A plan to do a third surgery in october to determine if the mesh was still causing problems.She reported pain during intercourse, pain from left side to groin, and down leg.The patient also reported pain of the right knee.An ambulatory referral to physical therapy was made.The physician prescribed ibuprofen 800 mg tablet as needed for pain.On (b)(6) 2021, a patient communication was received.The patient reported pain on her right knee and on her back.She also reported mesh pain.On (b)(6) 2022, the patient was seen and examined for concerns of anxiety, adhd and for medication refill.She has been communicating with lawyers and doctors regarding pain from mesh.She has been given a list of specialists to choose from to see about this.She has brought copies of these communications for her chart.The patient reported current abdominal pain which was 5 out of 10.The patient stated she had 2-3 days a week where pain was "unbearable." the patient was also here to follow up for adhd.The patient was doing well on adderall.It was effective by improving focus and there were no side effects noted.The patient's weight was stable.Her sleep was not affected.Pmp was reviewed today.Patient was doing well on xanax and she was requesting for refill.On (b)(6) 2022, a patient communication was received.The patient reported that she was experiencing worsening knee and mesh complications.On (b)(6) 2022, a patient communication was received.The patient requested a referral to see a physician in opelousas, la for her mesh pain.The patient was hoping to see the physician at the end of september but she needed to schedule the physician.
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Event Description
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It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted during a pubovaginal sling (pvs) with anterior repair procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence and cystocele.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient returned for the second post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on (b)(6) 2019.The patient reported vaginal pain, pelvic pain, and vaginal discharge that developed 6 weeks ago.The pelvic pain was described as mild in severity, with a score of 5.The vaginal discharge began 6 weeks ago and was described as clear, white, and foul-smelling.The patient also complained of burning/dysuria.Exam revealed yellow-colored vaginal discharge and the presence of sutures.The incision sites were healing well.Silver nitrate was applied to the vaginal cuff.A cbc was normal, and urinalysis was negative.Ultrasound and follow-up with the surgeon were planned.On (b)(6) 2019, the patient underwent an excision of the pubovaginal sling graft and vaginal wound closure due to graft extrusion.During the procedure, a foley catheter was placed for gravity drainage.The above-mentioned graft extrusion is approximately 0.5cm in size exposed.The graft was carefully and bluntly manipulated to free the graft bilaterally after incising the vaginal mucosa vertically and freeing the vaginal mucosa bilaterally as far back as the endopelvic fascia.The graft was excised on both sides and discarded.The vaginal wall was then closed without tension with a 2-0 vicryl running suture.It should be noted that a copious amount of antibiotic irrigation was utilized throughout the case.Vaginal packing was placed, and the foley was left to gravity drainage.She tolerated the procedure well, with no complications.She returned to recovery in stable condition.On (b)(6) 2019, the patient returned for the 5th post-operative evaluation after undergoing a laparoscopically assisted vaginal hysterectomy (lavh), bilateral salpingectomy, anterior repair, and pubovaginal sling (pvs) on (b)(6) 2019.A week ago, the patient had sling repair erosion.The patient reported pelvic pain that developed 3 weeks ago, and it was described as moderate in severity.Additionally, the patient had a history of ovarian cysts.Pelvic ultrasound revealed a right ovarian cyst.Additional information received on november 7, 2022.Patient history: on (b)(6) 2019, the patient was seen and examined for follow up and medication refill.The patient was followed-up for bipolar disorder, attention deficit hyperactivity disorder, generalized anxiety disorder and depressive disorder.All of these reportedly started on (b)(6) 2017.In addition, the patient also experienced intervertebral prolapse, degeneration of intervertebral disc, chronic back pain, fibromyalgia and ulnar neuropathy of the left arm.All of these problems also started on (b)(6) 2017.The patient also reported to have hives in the upper back the previous day with an unsure cause.On (b)(6) 2021, the patient was seen and examined via video.The patient had no chief complaints for this encounter.The patient started pt for her back pain.The patient was reportedly going to the gym.Sometime in march, the patient injured her right knee.Pt looked at and stated it was acl.She reinjured the day after last appointment.She stated she heard loud pop.The patient also reported that her back was still painful.In (b)(6) 2019, she had hysterectomy and bladder lift performed.At that time, a mesh was placed.In (b)(6) 2019, a second surgery due to mesh erosion was performed.A plan to do a third surgery in october to determine if the mesh was still causing problems.She reported pain during intercourse, pain from left side to groin, and down leg.The patient also reported pain of the right knee.An ambulatory referral to physical therapy was made.The physician prescribed ibuprofen 800 mg tablet as needed for pain.On (b)(6) 2021, a patient communication was received.The patient reported pain on her right knee and on her back.She also reported mesh pain.On (b)(6) 2022, the patient was seen and examined for concerns of anxiety, adhd and for medication refill.She has been communicating with lawyers and doctors regarding pain from mesh.She has been given a list of specialists to choose from to see about this.She has brought copies of these communications for her chart.The patient reported current abdominal pain which was 5 out of 10.The patient stated she had 2-3 days a week where pain was "unbearable." the patient was also here to follow up for adhd.The patient was doing well on adderall.It was effective by improving focus and there were no side effects noted.The patient's weight was stable.Her sleep was not affected.Pmp was reviewed today.Patient was doing well on xanax and she was requesting for refill.On (b)(6) 2022, a patient communication was received.The patient reported that she was experiencing worsening knee and mesh complications.On (b)(6) 2022, a patient communication was received.The patient requested a referral to see a physician in opelousas, la for her mesh pain.The patient was hoping to see the physician at the end of september but she needed to schedule the physician.Additional information received on july 19, 2023.On (b)(6) 2022, the patient reported a gynecological problem.During the physical examination, it was discovered that the patient was experiencing vulvar atrophy with hypopigmentation, which was tender to the touch with a q-tip at the posterior vestibule.In addition, the patient has reported experiencing fatigue but has not experienced any significant weight gain or weight loss.The patient complained of vaginal, abdominal, and buttock pain.She states that is has been constant since she had surgery.She had mesh placement and laparoscopic hysterectomy in (b)(6) 2019.She then had a piece of mesh removed due to erosion in (b)(6) 2019.She reports daily pain in lower pelvis and left lower quadrant pain that radiates down her left leg.This is worsened when sitting.Review of system: gastrointestinal: abdominal pain, bowel movement changes, diarrhea, constipation, and rectal bleeding were noted.Genitourinary: the patient was experiencing trouble urinating, as well as urinary frequency, urgency, incontinence, and vaginal discharge with an odor.Sexual: the patient reports having dyspareunia but has no decreased libido, orgasmic dysfunction, and vaginismus.Psychological: the patient displayed symptoms of anxiety, but there were no indications of depression.Hematologic/lymphatic: it was observed that the patient bruises easily.The physician has provided an assessment of the patient's condition and has suggested a plan of treatment.Lesion of the vulva.Pain in the pelvis (pelvic and perineal pain).Pudendal neuralgia: treatment: gabapentin 300 mg capsule.The patient should take one capsule orally, three times a day.Hip pain (hypertonic pelvic floor dysfunction): the patient was referred to urogynecology physical therapy.She was also prescribed a baclofen suppository of 10 mg, once per night at bedtime or as needed, inserted vaginally.Dyspareunia: the patient was prescribed to undergo medication and tests for dihydrotestosterone, hepatic function panel, estradiol serum, progesterone serum, prolactin serum, lipid panel, testosterone free and total, vitamin d, 25-hydroxy, total, serum, complete blood count with differential and platelet count, calcium blood test, sex hormone binding globulin and follicle stimulation hormone.
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Manufacturer Narrative
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Blocks b5 (event description), e1 (initial reporter zip/post code and initial reporter phone) and h6 (patient and impact codes) has been updated based on the additional information received on july 19, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon and healthcare facility are: (b)(6).The revision surgeon and healthcare facility are: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2002 - has been used to capture the reported event of patient easily gets bruises.E2330- has been used to capture the reported event of pain.E2006 - has been used to capture the reported event of erosion.E1405 - has been used to capture the reported event of painful intercourse.E020201 - has been used to capture the reported event of anxiety.E1301 - has been used to capture the reported event of trouble urinating.E0123 - has been used to capture the reported event of pudendal neuralgia.E1401 - has been used to capture the reported event of vaginal discharge with odor.The following imdrf impact codes capture the reportable events of: f23 - has been used to capture the reported event of medication prescribed to the patient.F1905 - has been used to capture the reported event of device revision.F18 - has been used to capture the reported event of physical therapy.
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