|
BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
| Model Number M0068503000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Fatigue (1849); Micturition Urgency (1871); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Prolapse (2475); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 05/10/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence and severe pmdd.On (b)(6) 2017, she was implanted with a lynx system device during exam under anesthesia + laparoscopic bilateral-oophorectomy + midureteral sling + cystoscopy procedure.The patient tolerated the procedure well.She recovered from her anesthesia and was transferred to the recovery room in stable condition.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2021.
|
| |
|
Manufacturer Narrative
|
|
The exact event onset date is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date of the mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
| |
|
Manufacturer Narrative
|
|
Block h2: additional information.Block b5 narrative updated.Block h6 patient codes added.Block h6 impact codes added.Correction: block b3 date of event updated.Block g2 report source updated.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 10, 2017, 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 surgeon is: dr.(b)(6).Attending physician: dr.(b)(6) medical center.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Block h6: patient code e1405, e020201, e1715, e0123,e020202, e2402, e2330 and e1301 capture the reportable events of dyspareunia, anxiety, scar tissue, nerve damage, depression, distention, pain and dysuria.Impact code f1903, f1202, captures the reportable event of mesh removal, disabilit and multiple nerve blocks.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
| |
|
Event Description
|
|
It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence and severe pmdd.On (b)(6) 2017, she was implanted with a lynx system device during exam under anesthesia + laparoscopic bilateral-oophorectomy + midurethral sling + cystoscopy procedure.The patient tolerated the procedure well.She recovered from her anesthesia and was transferred to the recovery room in stable condition.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2021.Boston scientific received an additional information on july 18, 2022, as follows: the patient experienced severe pelvic pain and burning in the groin starting the day after the implantation of the mid-urethral sling, which she described as extremely excruciating and radiating into the pubic bone.The doctor was informed of the problem and mostly recommended the patient take several medications.When the patient's condition didn't improve after three months, the doctor informed her that it was probably the result of complex scar tissue forming.The patient was referred for pelvic floor therapy, which she carried out over a five-month period, three times per week, which she reported gave her very little benefit.She claims that during these two to three months, she was extremely sensitive to touch and that the initial treatment had no effect on her condition.In (b)(6) 2018 after a year, the pain continued to be severe and she was unable to engage in sexual activity, despite gradually showing signs of improvement.Late in 2018, she was referred to another gynecologist, who recommended a mona lisa treatment as potentially being beneficial, and that it might help with the pain, because at the point, she was unable to sit due to the pain.She could tolerate a brief car ride but became extremely uncomfortable as the length of the car ride progressed past 10-15 minutes.She had an exam with a physician and was recommended to have a physical therapy, but she indicated that this really had not been found to be helpful before.The patient was given vaginal suppositories, three per day, which were very painful for her to insert.She used to use these primarily to help get to sleep as she would get some suppression of the pain symptoms.Overall, she had very significant lifestyle changes.She was unable to do her usually activities such as running.She had severe pain increase at night, more than during the day.She tried to do some of her usual work activities and volunteer activities, and all of these would precipitate severe pain.The patient would wake up with pain and was unable to engage in sexual intimacy due to the pain symptoms.Another further change developed in march 2021, when she had a sense of something moving or shifting.The next day, she began to feel a sense of pressure or bulging in the low perineal area and she and a significant increase in the severity of the incontinence as well as sharp, knife-like pain if she would sit more than about 45 minutes.She tried to increase her activity level to see if this would help.She tried some tennis in (b)(6) 2021, and this cause a severe cramping and some abdominal wall swelling.This would increase with activity or increase with sitting and she and been up to that point able to drive her son to school but her length of time that she could tolerate for driving was about 15 minutes and then it dropped to really no time at all.The patient tried to walk on an elliptical for exercise but was unable to do so.She was also unable to lie flat on her back.On (b)(6), 2021, the patient reports that she leaks large amounts of urine, and she cannot tell when the urine is coming out, only after her clothes are wet.She reports that she leaks when she coughs, sneeze or laugh.However, she denies leakage of urine with urge or on the way to the bathroom.The patient also claims that she felt a bulge, or something is falling out of her vagina and finds it bothersome.Reportedly, the pain continued to be severe and reports pain during intercourse.On (b)(6) 2021, the patient presented as a new patient to a hernia center for left lower quadrant pain, left groin pain, and pain that radiated to the back, leg and labia.The patient reports that the pain has spread to her left inner thigh and vagina.She also has generalized abdominal pain, bloating, and nausea.She describes prolonged cramping in the lower left quadrant (llq) and left upper quadrant (luq and she felt as though something had moved or that her "sling had come off".Reportedly, wiping after going to the bathroom causes her to have pinching pain in the region.She can also feel a bulging in the area, which she first noticed a few weeks ago.The bulge is more prominent when active, such as when walking or lifting.The area is painful with sitting or when the pelvis is upright.She is too sore to have intercourse.Notably, her urinary leakage has started since this pain started, e.G., during exercise.She describes no sensation that she has leaked her urine until she is drenched.She was seen by a urologist, had a vaginal examination, and was told she may have a muscle spasm.She was told there was no mesh erosion that could be felt and was prescribed a vaginal suppository.According to the physician, the patient should focus on addressing these problems as a complication from her mid-urethral sling.The patient is quite tender over the suprapubic region, where the tapes of these sling are pulled.The physician confirmed with the patient that they do not feel she has any hernia or hernia-related problem that is contributing to her symptoms.The physician also does not feel that all her symptoms are related to pelvic floor dysfunction.On (b)(6), 2021, the patient was seen via telemedicine at a clinic for chronic pain for perineal, vaginal, and rectal pain.She reported that she had difficulties sitting and standing for prolonged period.She had seen pelvic floor physical therapy and tried valium vaginal suppositories.Initially the suppositories were helping but now they are not.Patient is an avid tennis player and unable to play because of the pain.She feels that her abdomen is constantly swollen.She feels that this pain significantly affects her life.Also, her husband feels that the vaginal sling is quite rigid and uncomfortable during intercourse.Recently, she started experiencing hearing loss especially at night.She has urinary urgency and hesitancy.She is interested in mesh removal for treatment of this neuropathic pelvic pain.The assessment was urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials.The patient was advised she has all the symptoms consistent with pudendal neuralgia and spastic pelvic floor.The plan was for mesh removal and botox injections in to the pelvic floor muscles.The patient was seen on (b)(6) 2021, for examination since her pelvic pain had been worse over the previous four weeks.She claims that since getting her sling, she has experienced continual pelvic pain.She underwent pelvic floor physical therapy (pfpt) for seven months following surgery and experienced relief.Since then, she has used vaginal baclofen as required.She comes in for a cystourethroscopy at the clinic.On (b)(6), 2021, she had a negative urine culture.Additionally, she experiences pain in her thighs, lower abdomen, back, and armpits.She rates her stomach cramps as 10/10 on a pain scale, with lying on her left side seeming to marginally lessen the discomfort.The patient also claims that she suffers from abdominal swelling, bloating, and distention.The patient claims that after going for a stroll, she returns with stomach distention and seems to be seven months pregnant.She reports constipation and rare fecal urgency after spasm.When her bladder is full, she reportedly feels a cramping pain in her abdomen.She mentions dyspareunia and needs to use a vaginal suppository before having sex.In addition to recent uncontrolled flooding incontinence, she claims to also experience vaginal numbness and episodic burning.She says she was unaware of these symptoms at the time, but she becomes aware of them when she wakes up or while exercising.During her pelvic examination, a significant vaginal atrophy, uterine tenderness, tenderness at pubic bone and slight vaginal scarring was observed.Additionally, during cystoscopy, her bladder was inspected and no evidence of bladder tumors, stones, or foreign bodies.A slight hyperemia/hypervascularity was present.Ureteral orifices were also visualized.Efflux was seen from both ureters and no mesh exposure or erosion was seen into the bladder or urethra.Reportedly, the patient tolerated the procedure well.On (b)(6) 2021, the patient reports pain which feels like a butter knife is stabbing in the vagina which reportedly worsen after long periods of standing and sitting.She also reports stress urinary incontinence and unable to work out due to having almost complete loss of urine from bladder.During pelvic exam, the following was observed: - hypertonic pelvic floor muscles with no specific point of tenderness.- puborectalis, iliococcygeus and obturator muscles were palpated bilaterally.- tenderness to palpation in bilateral fornices at the level of pubic rami where her sling is located.- the sling itself is not palpable and there is no exposure.The physician discussed with the patient that her original surgery likely triggered pelvic floor pain which has evolved over the years to myofascial pelvic pain and hypertonic pelvic floor muscles.While the trigger may have been the original surgery, exam does not reveal specific tenderness of the mesh.The physician discussed that it would be reasonable to start with pelvic floor physical therapy (pfpt) and botox to the pelvic muscles.If her symptoms are not improved significantly enough with this conservative measure, then they could consider excision of mesh in the future.On (b)(6) 2021, the patient underwent a bilateral pudendal nerve block and injection of botox into the pelvic floor for the treatment of pelvic pain and pelvic floor dysfunction.During the procedure, the patient was placed in lithotomy position, prepped and draped in the usual manner.The ischial spine was identified on the right side via palpation through the vagina.Through the posterior vaginal wall, the idaho trumpet needle was advanced medial and anterior to the ischial spine.10 ml of 0% marcaine was injected into this area.The identical procedure was done on the patient's left side.200 units of botox was diluted in 10 ml of normal saline.The obturator, iliococcygeus and puborectalis muscles were identified on the right side.Using the same needle, 5 ml of the solution or 100 units was injected into those muscles on the right side followed by the same injection into the muscles on the left side.1 ml of normal saline was used to clear the injection needle of any residual botox solution.The patient tolerated the procedure well and was returned to recovery in stable condition.As of (b)(6) 2021, the patient has failed multiple conservative treatment including botox injection into pelvic floor muscles.The physician decided to proceed with vaginal and robotic removal of retropubic mesh, kelly plication and possible cystoscopy.All the risks and benefits of the surgery were explained to the patient including the risk of delayed or unrecognized bowel injury and injury to the urinary system.Patient also understands that she is at the high risk of recurrence of her incontinence.They also have discussed the fact that if her incontinence recurs, she may need to pressure bladder sling procedure to repair incontinence.The assessment was causalgia, urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials reportedly, the mesh removal was performed on (b)(6), 2021.According to reports, the surgery helped the patient quite a bit.Her upper abdominal pain was almost completely resolved, and she did have a plan to proceed on to do additional botox injections, which have not been done yet because of her low pelvic pain continued to be severe.On (b)(6) 2021, the patient was still lying in bed on her left side, but she said she was significantly better.She says that immediately after surgery there was a change in sensation in her abdomen and pelvis.Patient calls it miraculously better.She feels however that her sitting pain is worse.Patient says that before surgery she was not able to express how much pain she was in and how did the mesh injure her.It is only after the mesh was removed that she can tell the difference.She has been on gabapentin with minimal effect.The pain is aggravated by sitting or standing.She gets some relief from lying on her left side in the past but since the surgery in june, the left side is uncomfortable as well as to the low pelvis.Overall, the pain has been at a steady level.On (b)(6) 2021, the patient was seen at a nerve clinic.She noted on the pain diagram that she is experiencing pain in the right mid-to-low buttocks area, some numbness in the posterior thigh on both sides, some pain along the medial upper thigh, pain in the midline of the buttock area, pain in the low anterior abdomen, pain in the pubic area, and pain in the inguinal crease medially.She noted some numbness in her toes.At the time of the evaluation, the patient assesses the pain as being between 9 and 10, with 10 being the worst and 8 the best.She also claims that she experiences ongoing discomfort, including positional pain and occasional aggravations, and that she is completely immobilized.She struggles to rest on her left side on a couch and has trouble getting up, moving around, lying down, or sleeping.Furthermore, the patient had been referred to physical therapist specializing in pelvic pain syndromes from whom she was given some advice about further physical therapy, but at this point, she continues to be quite disabled by the low pelvic pain.Immediately following the surgery in (b)(6), although the upper abdominal symptoms were improved, she was immediately aware of the severe problems with her low pelvis.She was feeling unable to walk, sitting was still impossible.There was still the severe lower abdominal pain to a level 10, even though the upper pain was improved.She was unable to stand, unable to walk debilitated, unable to lie down and physical therapy told that her condition was so severe that she was not sure physical therapy would be an appropriate next step.Following exam on (b)(6), 2021, the physician's impression included impar ganglion syndrome given the symptoms of burning pain in the pelvic-genital region, severe sensitivity of the sacroiliac joint, and urinary incontinence; concurrent pudendal neuralgia; and piriformis syndrome which was noted to be a cause for pudendal syndrome and obturator internus nerve irritation.It was further explained to the patient that while the mesh removal treated certain aspects of her pain, other pain was left unaffected due, in the physician's opinion, to untreated impar ganglion syndrome, untreated severe piriformis syndrome causing compression of the nerve to the obturator internus at the level of the ischial spine along with the pudendal impingement.It was further noted that sometimes the link between the impar syndrome and the piriformis-obturator internus syndrome is a nerve branch of the nerve to the obturator internus and may also innervate the coccygeus muscle causing spasm and pulling of the coccyx against the impar ganglion.The patient was advised that she would need mri-guided injections and would likely require surgical treatment.On (b)(6) 2021, the patient underwent a neurography.Impression of procedure stated that the patient had complex tarlov's cyst associated with the s4 spinal nerve on the right with large extensions of the neural cyst on the medial aspect of the piriformis muscle, unless these are unusual or dilated veins or even a foreign body of some type.At the level of the ischial spine on the right side there is some evidence of some entrapment or irritation affecting the pudendal nerve.There is hypersensitivity in the area of the sacroiliac joint on its anterior aspect in the area of the impart ganglion.There is a significant defect in the area of the right pubococcygeal region from prior surgery, approximately 20 years earlier, which was done for the presence of a cyst as per the patient.Overall, these findings demonstrate multiple abnormalities including the tarlov's cysts, the entrapment of the right pudendal nerve at the ischial spine, the deformation of the area of the lateral aspect of the sacrococcygeal joint on the left side hyperintensity in the area of the impar ganglion anterior to the remaining portion of the sacrococcygeal joint.Overall, these findings indicate the complex anatomy that is underlying the current symptoms and the degree of abnormality strongly supports the likelihood of demonstrating sufficient severity of an abnormality as to expect clinically significant symptoms.On (b)(6) 2021, the patient presented for physical therapy.It was noted she had been in pt for 4 months.She was struggling mentally with her condition, and was able to stand for 10 minutes the day prior but was very fatigued today, though not as fatigued as she once was.She was 3 weeks out from her procedure.The assessment was that the patient continued to respond well to physical therapy interventions that focus on down regulation of central nervous systems with desensitization techniques, and manual therapy.On (b)(6) 2022, spinal x-rays showed l4-5 degenerative disc disease (ddd) and lower lumbar facet arthropathy.On (b)(6) 2022, the patient presented to a spine center with the chief complaints of s4 tarlov cyst and possible right pudendal nerve entrapment, l4-5 ddd, and status post multiple injections including nerve blocks at pudendal nerve, obturator, impar ganglion, and piriformis with 60% improvement within 2 hours of the nerve block with waning after 6 days.She was taking percocet 5mg as needed.As of (b)(6), 2022, the patient was able to sit and stand for longer periods of time since the injections.In addition, the patient was undergoing a gastrointestinal work up and is planning to eventually have a colonoscopy to further evaluate her rectal pain.She also notes a history of neck pain which has worsened since her pelvic symptoms worsened.She has not completed recent physical therapy.Her surgeon will get imaging to further evaluate this complaint as well.The plan was sacral mri with tarlov cyst protocol, lumbar spine mri, request injection records, follow-up for neurogenital testing, cervical spine x-rays and mri for persistent neck pain, cervical spine pt, and telemedicine appointment after sacral mri and follow-up after that.
|
| |
|
Manufacturer Narrative
|
|
Blocks b5 and e1 (initial reporter zip/post code) has been updated based on the additional information received on january 12, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 10, 2017, was chosen as a best estimate based on the date of the mesh was implanted.Blocks 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 surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2311 - discomfort e2330 - pain e1705 - burning sensation e1405 - dyspareunia e020201 - anxiety e1715 - scar tissue e1301 - dysuria e0123 - nerve damage e020202 - depression.The following imdrf impact codes capture the reportable events of: f2303 - medication required f1202 - disability f18 - rehabilitation f23 - unexpected medical intervention f1903 - device explantation.
|
| |
|
Event Description
|
|
It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence and severe pmdd.On (b)(6) 2017, she was implanted with a lynx system device during exam under anesthesia + laparoscopic bilateral-oophorectomy + midurethral sling + cystoscopy procedure.The patient tolerated the procedure well.She recovered from her anesthesia and was transferred to the recovery room in stable condition.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2021.Boston scientific received an additional information on july 18, 2022, as follows: the patient experienced severe pelvic pain and burning in the groin starting the day after the implantation of the mid-urethral sling, which she described as extremely excruciating and radiating into the pubic bone.The doctor was informed of the problem and mostly recommended the patient take several medications.When the patient's condition didn't improve after three months, the doctor informed her that it was probably the result of complex scar tissue forming.The patient was referred for pelvic floor therapy, which she carried out over a five-month period, three times per week, which really gave her very little benefit.She claims that during these two to three months, she was extremely sensitive to touch and that the initial treatment had no effect on her condition.In may 2018 after a year, the pain continued to be severe and she was unable to engage in sexual activity, despite gradually showing signs of improvement.Late in 2018, she was referred to another gynecologist, who recommended a mona lisa treatment as potentially being beneficial, and that it might help with the pain, because at the point, she was unable to sit due to the pain.She could tolerate a brief car ride but became extremely uncomfortable as the length of the car ride progressed past 10-15 minutes.She had an exam with a physician and was recommended to have a physical therapy, but she indicated that this really had not been found to be helpful before.The patient was given vaginal suppositories, three per day, which were very painful for her to insert.She used to use these primarily to help get to sleep as she would get some suppression of the pain symptoms.Overall, she had very significant lifestyle changes.She was unable to do her usually activities such as running.She had severe pain increase at night, more than during the day.She tried to do some of her usual work activities and volunteer activities, and all of these would precipitate severe pain.The patient would wake up with pain and was unable to engage in sexual intimacy due to the pain symptoms.Another further change developed in (b)(6) 2021, when she had a sense of something moving or shifting.The next day, she began to feel a sense of pressure or bulging in the low perineal area and she and a significant increase in the severity of the incontinence as well as sharp, knife-like pain if she would sit more than about 45 minutes.She tried to increase her activity level to see if this would help.She tried some tennis in (b)(6) 2021, and this cause a severe cramping and some abdominal wall swelling.This would increase with activity or increase with sitting and she and been up to that point able to drive her son to school but her length of time that she could tolerate for driving was about 15 minutes and then it dropped to really no time at all.The patient tried to walk on an elliptical for exercise.Also was unable to do this.She was also unable to lie flat on her back.On (b)(6) 2021, the patient reports that she leaks large amounts of urine, and she cannot tell when the urine is coming out, only after her clothes are wet.She reports that she leaks when she coughs, sneeze or laugh.However, she denies leakage of urine with urge or on the way to the bathroom.The patient also claims that she felt a bulge, or something is falling out of her vagina and finds it bothersome.Reportedly, the pain continued to be severe and reports pain during intercourse.On (b)(6) 2021, the patient presented as a new patient to a hernia center for left lower quadrant pain, left groin pain, and pain that radiated to the back, leg and labia.The patient reports that the pain has spread to her left inner thigh and vagina.She also has generalized abdominal pain, bloating, and nausea.She describes prolonged cramping in the lower left quadrant (llq) and left upper quadrant (luq and she felt as though something had moved or that her "sling had come off".Reportedly, wiping after going to the bathroom causes her to have pinching pain in the region.She can also feel a bulging in the area, which she first noticed a few weeks ago.The bulge is more prominent when active, such as when walking or lifting.The area is painful with sitting or when the pelvis is upright.She is too sore to have intercourse.Notably, her urinary leakage has started since this pain started, e.G., during exercise.She describes no sensation that she has leaked her urine until she is drenched.She was seen by a urologist, had a vaginal examination, and was told she may have a muscle spasm.She was told there was no mesh erosion that could be felt and was prescribed a vaginal suppository.According to the physician, the patient should focus on addressing these problems as a complication from her mid-urethral sling.The patient is quite tender over the suprapubic region, where the tapes of these sling are pulled.The physician confirmed with the patient that i do not feel she has any hernia or hernia-related problem that is contributing to her symptoms.The physician also does not feel that all her symptoms are related to pelvic floor dysfunction.On (b)(6) 2021, the patient was seen via telemedicine at a clinic for chronic pain for perineal, vaginal, and rectal pain.She reported that she had difficulties sitting and standing for prolonged period.She had seen pelvic floor physical therapy and tried valium vaginal suppositories.Initially the suppositories were helping but now they are not.Patient is an avid tennis player and unable to play because of the pain.She feels that her abdomen is constantly swollen.She feels that this pain significantly affects her life.Also, her husband feels that the vaginal sling is quite rigid and uncomfortable during intercourse.Recently, she started experiencing hearing loss especially at night.She has urinary urgency and hesitancy.She is interested in mesh removal for treatment of this neuropathic pelvic pain.The assessment was urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials.The patient was advised she has all the symptoms consistent with pudendal neuralgia and spastic pelvic floor.The plan was for mesh removal and botox injections in to the pelvic floor muscles.The patient was seen on (b)(6) 2021, for examination since her pelvic pain had been worse over the previous four weeks.She claims that since getting her sling, she has experienced continual pelvic pain.She underwent pelvic floor physical therapy (pfpt) for seven months following surgery and experienced relief.Since then, she has used vaginal baclofen as required.She comes in for a cystourethroscopy at the clinic.On (b)(6) 2021, she had a negative urine culture.Additionally, she experiences pain in her thighs, lower abdomen, back, and armpits.She rates her stomach cramps as 10/10 on a pain scale, with lying on her left side seeming to marginally lessen the discomfort.The patient also claims that she suffers from abdominal swelling, bloating, and distention.The patient claims that after going for a stroll, she returns with stomach distention and seems to be seven months pregnant.She reports constipation and rare fecal urgency after spasm.When her bladder is full, she reportedly feels a cramping pain in her abdomen.She mentions dyspareunia and needs to use a vaginal suppository before having sex.In addition to recent uncontrolled flooding incontinence, she claims to also experience vaginal numbness and episodic burning.She says she was unaware of these symptoms at the time, but she becomes aware of them when she wakes up or while exercising.During her pelvic examination, a significant vaginal atrophy, uterine tenderness, tenderness at pubic bone and slight vaginal scarring was observed.Additionally, during cystoscopy, her bladder was inspected and no evidence of bladder tumors, stones, or foreign bodies.A slight hyperemia/hypervascularity was present.Ureteral orifices were also visualized.Efflux was seen from both ureters and no mesh exposure or erosion was seen into the bladder or urethra.Reportedly, the patient tolerated the procedure well.On (b)(6) 2021, the patient reports pain which feels like a butter knife is stabbing in the vagina which reportedly worsen after long periods of standing and sitting.She also reports stress urinary incontinence and unable to work out due to having almost complete loss of urine from bladder.During pelvic exam, the following was observed: - hypertonic pelvic floor muscles with no specific point of tenderness.- puborectalis, iliococcygeus and obturator muscles were palpated bilaterally.- tenderness to palpation in bilateral fornices at the level of pubic rami where her sling is located.- the sling itself is not palpable and there is no exposure.The physician discussed with the patient that her original surgery likely triggered pelvic floor pain which has evolved over the years to myofascial pelvic pain and hypertonic pelvic floor muscles.While the trigger may have been the original surgery, exam does not reveal specific tenderness of the mesh.The physician discussed that it would be reasonable to start with pelvic floor physical therapy (pfpt) and botox to the pelvic muscles.If her symptoms are not improved significantly enough with this conservative measure, then they could consider excision of mesh in the future.On (b)(6) 2021, the patient underwent a bilateral pudendal nerve block and injection of botox into the pelvic floor for the treatment of pelvic pain and pelvic floor dysfunction.During the procedure, the patient was placed in lithotomy position, prepped and draped in the usual manner.The ischial spine was identified on the right side via palpation through the vagina.Through the posterior vaginal wall, the idaho trumpet needle was advanced medial and anterior to the ischial spine.10 ml of 0% marcaine was injected into this area.The identical procedure was done on the patient's left side.200 units of botox was diluted in 10 ml of normal saline.The obturator, iliococcygeus and puborectalis muscles were identified on the right side.Using the same needle, 5 ml of the solution or 100 units was injected into those muscles on the right side followed by the same injection into the muscles on the left side.1 ml of normal saline was used to clear the injection needle of any residual botox solution.The patient tolerated the procedure well and was returned to recovery in stable condition.As of (b)(6) 2021, the patient has failed multiple conservative treatment including botox injection into pelvic floor muscles.The physician decided to proceed with vaginal and robotic removal of retropubic mesh, kelly plication and possible cystoscopy.All the risks and benefits of the surgery were explained to the patient including the risk of delayed or unrecognized bowel injury and injury to the urinary system.Patient also understands that she is at the high risk of recurrence of her incontinence.They also have discussed the fact that if her incontinence recurs, she may need to pressure bladder sling procedure to repair incontinence.The assessment was causalgia, urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials reportedly, the mesh removal was performed on (b)(6) 2021.According to reports, the surgery helped the patient quite a bit.Her upper abdominal pain was almost completely resolved, and she did have a plan to proceed on to do additional botox injections, which have not been done yet because of her low pelvic pain continued to be severe.On (b)(6) 2021, the patient was still lying in bed on her left side, but she said she was significantly better.She says that immediately after surgery there was a change in sensation in her abdomen and pelvis.Patient calls it miraculously better.She feels however that her sitting pain is worse.Patient says that before surgery she was not able to express how much pain she was in and how did the mesh injure her.It is only after the mesh was removed that she can tell the difference.She has been on gabapentin with minimal effect.The pain is aggravated by sitting or standing.She gets some relief from lying on her left side in the past but since the surgery in june, the left side is uncomfortable as well as to the low pelvis.Overall, the pain has been at a steady level.On (b)(6) 2021, the patient was seen at a nerve clinic.She noted on the pain diagram that she is experiencing pain in the right mid-to-low buttocks area, some numbness in the posterior thigh on both sides, some pain along the medial upper thigh, pain in the midline of the buttock area, pain in the low anterior abdomen, pain in the pubic area, and pain in the inguinal crease medially.She noted some numbness in her toes.At the time of the evaluation, the patient assesses the pain as being between 9 and 10, with 10 being the worst and 8 the best.She also claims that she experiences ongoing discomfort, including positional pain and occasional aggravations, and that she is completely immobilized.She struggles to rest on her left side on a couch and has trouble getting up, moving around, lying down, or sleeping.Furthermore, the patient had been referred to physical therapist specializing in pelvic pain syndromes from whom she was given some advice about further physical therapy, but at this point, she continues to be quite disabled by the low pelvic pain.Immediately following the surgery in june, although the upper abdominal symptoms were improved, she was immediately aware of the severe problems with her low pelvis.She was feeling unable to walk, sitting was still impossible.There was still the severe lower abdominal pain to a level 10, even though the upper pain was improved.She was unable to stand, unable to walk debilitated, unable to lie down and physical therapy told that her condition was so severe that she was not sure physical therapy would be an appropriate next step.Following exam on (b)(6) 2021, the physician's impression included impar ganglion syndrome given the symptoms of burning pain in the pelvic-genital region, severe sensitivity of the sacroiliac joint, and urinary incontinence; concurrent pudendal neuralgia; and piriformis syndrome which was noted to be a cause for pudendal syndrome and obturator internus nerve irritation.It was further explained to the patient that while the mesh removal treated certain aspects of her pain, other pain was left unaffected due, in the physician's opinion, to untreated impar ganglion syndrome, untreated severe piriformis syndrome causing compression of the nerve to the obturator internus at the level of the ischial spine along with the pudendal impingement.It was further noted that sometimes the link between the impar syndrome and the piriformis-obturator internus syndrome is a nerve branch of the nerve to the obturator internus and may also innervate the coccygeus muscle causing spasm and pulling of the coccyx against the impar ganglion.The patient was advised that she would need mri-guided injections and would likely require surgical treatment.On (b)(6) 2021, the patient underwent a neurography.Impression of procedure stated that the patient had complex tarlov's cyst associated with the s4 spinal nerve on the right with large extensions of the neural cyst on the medial aspect of the piriformis muscle, unless these are unusual or dilated veins or even a foreign body of some type.At the level of the ischial spine on the right side there is some evidence of some entrapment or irritation affecting the pudendal nerve.There is hypersensitivity in the area of the sacroiliac joint on its anterior aspect in the area of the impart ganglion.There is a significant defect in the area of the right pubococcygeal region from prior surgery, approximately 20 years earlier, which was done for the presence of a cyst as per the patient.Overall, these findings demonstrate multiple abnormalities including the tarlov's cysts, the entrapment of the right pudendal nerve at the ischial spine, the deformation of the area of the lateral aspect of the sacrococcygeal joint on the left side hyperintensity in the area of the impar ganglion anterior to the remaining portion of the sacrococcygeal joint.Overall, these findings indicate the complex anatomy that is underlying the current symptoms and the degree of abnormality strongly supports the likelihood of demonstrating sufficient severity of an abnormality as to expect clinically significant symptoms.On (b)(6) 2021, the patient presented for physical therapy.It was noted she had been in pt for 4 months.She was struggling mentally with her condition, and was able to stand for 10 minutes the day prior but was very fatigued today, though not as fatigued as she once was.She was 3 weeks out from her procedure.The assessment was that the patient continued to respond well to physical therapy interventions that focus on down regulation of central nervous systems with desensitization techniques, and manual therapy.On (b)(6) 2022, spinal x-rays showed l4-5 degenerative disc disease (ddd) and lower lumbar facet arthropathy.On (b)(6) 2022, the patient presented to a spine center with the chief complaints of s4 tarlov cyst and possible right pudendal nerve entrapment, l4-5 ddd, and status post multiple injections including nerve blocks at pudendal nerve, obturator, impar ganglion, and piriformis with 60% improvement within 2 hours of the nerve block with waning after 6 days.She was taking percocet 5mg as needed.As of (b)(6) 2022, the patient was able to sit and stand for longer periods of time since the injections.In addition, the patient was undergoing a gastrointestinal work up and is planning to eventually have a colonoscopy to further evaluate her rectal pain.She also notes a history of neck pain which has worsened since her pelvic symptoms worsened.She has not completed recent physical therapy.Her surgeon will get imaging to further evaluate this complaint as well.The plan was sacral mri with tarlov cyst protocol, lumbar spine mri, request injection records, follow-up for neurogenital testing, cervical spine x-rays and mri for persistent neck pain, cervical spine pt, and telemedicine appointment after sacral mri and follow-up after that.Boston scientific received an additional information on january 12, 2023, as follows: on (b)(6) 2021, the patient underwent a robotic-assisted laparoscopic removal of retropubic mesh, vaginal removal of the retropubic sling, kelly plication, cystoscopy, and a bilateral pudendal nerve block to address the complications of the implanted sling, pudendal neuralgia, and spastic pelvic floor syndrome.The procedure findings were of properly placed retropubic mesh and significant bilateral spasm of pelvic floor muscles.There were no reported patient complications.
|
| |
|
Event Description
|
|
It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence and severe pmdd.On (b)(6) 2017, she was implanted with a lynx system device during exam under anesthesia + laparoscopic bilateral-oophorectomy + midurethral sling + cystoscopy procedure.The patient tolerated the procedure well.She recovered from her anesthesia and was transferred to the recovery room in stable condition.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2021.Boston scientific received an additional information on july 18, 2022, as follows: the patient experienced severe pelvic pain and burning in the groin starting the day after the implantation of the mid-urethral sling, which she described as extremely excruciating and radiating into the pubic bone.The doctor was informed of the problem and mostly recommended the patient take several medications.When the patient's condition didn't improve after three months, the doctor informed her that it was probably the result of complex scar tissue forming.The patient was referred for pelvic floor therapy, which she carried out over a five-month period, three times per week, which really gave her very little benefit.She claims that during these two to three months, she was extremely sensitive to touch and that the initial treatment had no effect on her condition.In (b)(6) 2018 after a year, the pain continued to be severe and she was unable to engage in sexual activity, despite gradually showing signs of improvement.Late in 2018, she was referred to another gynecologist, who recommended a mona lisa treatment as potentially being beneficial, and that it might help with the pain, because at the point, she was unable to sit due to the pain.She could tolerate a brief car ride but became extremely uncomfortable as the length of the car ride progressed past 10-15 minutes.She had an exam with a physician and was recommended to have a physical therapy, but she indicated that this really had not been found to be helpful before.The patient was given vaginal suppositories, three per day, which were very painful for her to insert.She used to use these primarily to help get to sleep as she would get some suppression of the pain symptoms.Overall, she had very significant lifestyle changes.She was unable to do her usually activities such as running.She had severe pain increase at night, more than during the day.She tried to do some of her usual work activities and volunteer activities, and all of these would precipitate severe pain.The patient would wake up with pain and was unable to engage in sexual intimacy due to the pain symptoms.Another further change developed in (b)(6) 2021, when she had a sense of something moving or shifting.The next day, she began to feel a sense of pressure or bulging in the low perineal area and she and a significant increase in the severity of the incontinence as well as sharp, knife-like pain if she would sit more than about 45 minutes.She tried to increase her activity level to see if this would help.She tried some tennis in (b)(6) 2021, and this cause a severe cramping and some abdominal wall swelling.This would increase with activity or increase with sitting and she and been up to that point able to drive her son to school but her length of time that she could tolerate for driving was about 15 minutes and then it dropped to really no time at all.The patient tried to walk on an elliptical for exercise.Also was unable to do this.She was also unable to lie flat on her back.On (b)(6) 2021, the patient reports that she leaks large amounts of urine, and she cannot tell when the urine is coming out, only after her clothes are wet.She reports that she leaks when she coughs, sneeze or laugh.However, she denies leakage of urine with urge or on the way to the bathroom.The patient also claims that she felt a bulge, or something is falling out of her vagina and finds it bothersome.Reportedly, the pain continued to be severe and reports pain during intercourse.On (b)(6) 2021, the patient presented as a new patient to a hernia center for left lower quadrant pain, left groin pain, and pain that radiated to the back, leg and labia.The patient reports that the pain has spread to her left inner thigh and vagina.She also has generalized abdominal pain, bloating, and nausea.She describes prolonged cramping in the lower left quadrant (llq) and left upper quadrant (luq and she felt as though something had moved or that her "sling had come off".Reportedly, wiping after going to the bathroom causes her to have pinching pain in the region.She can also feel a bulging in the area, which she first noticed a few weeks ago.The bulge is more prominent when active, such as when walking or lifting.The area is painful with sitting or when the pelvis is upright.She is too sore to have intercourse.Notably, her urinary leakage has started since this pain started, e.G., during exercise.She describes no sensation that she has leaked her urine until she is drenched.She was seen by a urologist, had a vaginal examination, and was told she may have a muscle spasm.She was told there was no mesh erosion that could be felt and was prescribed a vaginal suppository.According to the physician, the patient should focus on addressing these problems as a complication from her mid-urethral sling.The patient is quite tender over the suprapubic region, where the tapes of these sling are pulled.The physician confirmed with the patient that i do not feel she has any hernia or hernia-related problem that is contributing to her symptoms.The physician also does not feel that all her symptoms are related to pelvic floor dysfunction.On (b)(6) 2021, the patient was seen via telemedicine at a clinic for chronic pain for perineal, vaginal, and rectal pain.She reported that she had difficulties sitting and standing for prolonged period.She had seen pelvic floor physical therapy and tried valium vaginal suppositories.Initially the suppositories were helping but now they are not.Patient is an avid tennis player and unable to play because of the pain.She feels that her abdomen is constantly swollen.She feels that this pain significantly affects her life.Also, her husband feels that the vaginal sling is quite rigid and uncomfortable during intercourse.Recently, she started experiencing hearing loss especially at night.She has urinary urgency and hesitancy.She is interested in mesh removal for treatment of this neuropathic pelvic pain.The assessment was urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials.The patient was advised she has all the symptoms consistent with pudendal neuralgia and spastic pelvic floor.The plan was for mesh removal and botox injections in to the pelvic floor muscles.The patient was seen on (b)(6) 2021, for examination since her pelvic pain had been worse over the previous four weeks.She claims that since getting her sling, she has experienced continual pelvic pain.She underwent pelvic floor physical therapy (pfpt) for seven months following surgery and experienced relief.Since then, she has used vaginal baclofen as required.She comes in for a cystourethroscopy at the clinic.On (b)(6) 2021, she had a negative urine culture.Additionally, she experiences pain in her thighs, lower abdomen, back, and armpits.She rates her stomach cramps as 10/10 on a pain scale, with lying on her left side seeming to marginally lessen the discomfort.The patient also claims that she suffers from abdominal swelling, bloating, and distention.The patient claims that after going for a stroll, she returns with stomach distention and seems to be seven months pregnant.She reports constipation and rare fecal urgency after spasm.When her bladder is full, she reportedly feels a cramping pain in her abdomen.She mentions dyspareunia and needs to use a vaginal suppository before having sex.In addition to recent uncontrolled flooding incontinence, she claims to also experience vaginal numbness and episodic burning.She says she was unaware of these symptoms at the time, but she becomes aware of them when she wakes up or while exercising.During her pelvic examination, a significant vaginal atrophy, uterine tenderness, tenderness at pubic bone and slight vaginal scarring was observed.Additionally, during cystoscopy, her bladder was inspected and no evidence of bladder tumors, stones, or foreign bodies.A slight hyperemia/hypervascularity was present.Ureteral orifices were also visualized.Efflux was seen from both ureters and no mesh exposure or erosion was seen into the bladder or urethra.Reportedly, the patient tolerated the procedure well.On (b)(6) 2021, the patient reports pain which feels like a butter knife is stabbing in the vagina which reportedly worsen after long periods of standing and sitting.She also reports stress urinary incontinence and unable to work out due to having almost complete loss of urine from bladder.During pelvic exam, the following was observed: hypertonic pelvic floor muscles with no specific point of tenderness.Puborectalis, iliococcygeus and obturator muscles were palpated bilaterally.Tenderness to palpation in bilateral fornices at the level of pubic rami where her sling is located.The sling itself is not palpable and there is no exposure.The physician discussed with the patient that her original surgery likely triggered pelvic floor pain which has evolved over the years to myofascial pelvic pain and hypertonic pelvic floor muscles.While the trigger may have been the original surgery, exam does not reveal specific tenderness of the mesh.The physician discussed that it would be reasonable to start with pelvic floor physical therapy (pfpt) and botox to the pelvic muscles.If her symptoms are not improved significantly enough with this conservative measure, then they could consider excision of mesh in the future.On (b)(6) 2021, the patient underwent a bilateral pudendal nerve block and injection of botox into the pelvic floor for the treatment of pelvic pain and pelvic floor dysfunction.During the procedure, the patient was placed in lithotomy position, prepped and draped in the usual manner.The ischial spine was identified on the right side via palpation through the vagina.Through the posterior vaginal wall, the idaho trumpet needle was advanced medial and anterior to the ischial spine.10 ml of 0% marcaine was injected into this area.The identical procedure was done on the patient's left side.200 units of botox was diluted in 10 ml of normal saline.The obturator, iliococcygeus and puborectalis muscles were identified on the right side.Using the same needle, 5 ml of the solution or 100 units was injected into those muscles on the right side followed by the same injection into the muscles on the left side.1 ml of normal saline was used to clear the injection needle of any residual botox solution.The patient tolerated the procedure well and was returned to recovery in stable condition.As of (b)(6) 2021, the patient has failed multiple conservative treatment including botox injection into pelvic floor muscles.The physician decided to proceed with vaginal and robotic removal of retropubic mesh, kelly plication and possible cystoscopy.All the risks and benefits of the surgery were explained to the patient including the risk of delayed or unrecognized bowel injury and injury to the urinary system.Patient also understands that she is at the high risk of recurrence of her incontinence.They also have discussed the fact that if her incontinence recurs, she may need to pressure bladder sling procedure to repair incontinence.The assessment was causalgia, urge incontinence, pudendal neuralgia, and other specified complications due to other genitourinary prosthetic materials reportedly, the mesh removal was performed on (b)(6) 2021.According to reports, the surgery helped the patient quite a bit.Her upper abdominal pain was almost completely resolved, and she did have a plan to proceed on to do additional botox injections, which have not been done yet because of her low pelvic pain continued to be severe.On (b)(6) 2021, the patient was still lying in bed on her left side, but she said she was significantly better.She says that immediately after surgery there was a change in sensation in her abdomen and pelvis.Patient calls it miraculously better.She feels however that her sitting pain is worse.Patient says that before surgery she was not able to express how much pain she was in and how did the mesh injure her.It is only after the mesh was removed that she can tell the difference.She has been on gabapentin with minimal effect.The pain is aggravated by sitting or standing.She gets some relief from lying on her left side in the past but since the surgery in june, the left side is uncomfortable as well as to the low pelvis.Overall, the pain has been at a steady level.On (b)(6) 2021, the patient was seen at a nerve clinic.She noted on the pain diagram that she is experiencing pain in the right mid-to-low buttocks area, some numbness in the posterior thigh on both sides, some pain along the medial upper thigh, pain in the midline of the buttock area, pain in the low anterior abdomen, pain in the pubic area, and pain in the inguinal crease medially.She noted some numbness in her toes.At the time of the evaluation, the patient assesses the pain as being between 9 and 10, with 10 being the worst and 8 the best.She also claims that she experiences ongoing discomfort, including positional pain and occasional aggravations, and that she is completely immobilized.She struggles to rest on her left side on a couch and has trouble getting up, moving around, lying down, or sleeping.Furthermore, the patient had been referred to physical therapist specializing in pelvic pain syndromes from whom she was given some advice about further physical therapy, but at this point, she continues to be quite disabled by the low pelvic pain.Immediately following the surgery in june, although the upper abdominal symptoms were improved, she was immediately aware of the severe problems with her low pelvis.She was feeling unable to walk, sitting was still impossible.There was still the severe lower abdominal pain to a level 10, even though the upper pain was improved.She was unable to stand, unable to walk debilitated, unable to lie down and physical therapy told that her condition was so severe that she was not sure physical therapy would be an appropriate next step.Following exam on (b)(6) 2021, the physician's impression included impar ganglion syndrome given the symptoms of burning pain in the pelvic-genital region, severe sensitivity of the sacroiliac joint, and urinary incontinence; concurrent pudendal neuralgia; and piriformis syndrome which was noted to be a cause for pudendal syndrome and obturator internus nerve irritation.It was further explained to the patient that while the mesh removal treated certain aspects of her pain, other pain was left unaffected due, in the physician's opinion, to untreated impar ganglion syndrome, untreated severe piriformis syndrome causing compression of the nerve to the obturator internus at the level of the ischial spine along with the pudendal impingement.It was further noted that sometimes the link between the impar syndrome and the piriformis-obturator internus syndrome is a nerve branch of the nerve to the obturator internus and may also innervate the coccygeus muscle causing spasm and pulling of the coccyx against the impar ganglion.The patient was advised that she would need mri-guided injections and would likely require surgical treatment.On (b)(6) 2021, the patient underwent a neurography.Impression of procedure stated that the patient had complex tarlov's cyst associated with the s4 spinal nerve on the right with large extensions of the neural cyst on the medial aspect of the piriformis muscle, unless these are unusual or dilated veins or even a foreign body of some type.At the level of the ischial spine on the right side there is some evidence of some entrapment or irritation affecting the pudendal nerve.There is hypersensitivity in the area of the sacroiliac joint on its anterior aspect in the area of the impart ganglion.There is a significant defect in the area of the right pubococcygeal region from prior surgery, approximately 20 years earlier, which was done for the presence of a cyst as per the patient.Overall, these findings demonstrate multiple abnormalities including the tarlov's cysts, the entrapment of the right pudendal nerve at the ischial spine, the deformation of the area of the lateral aspect of the sacrococcygeal joint on the left side hyperintensity in the area of the impar ganglion anterior to the remaining portion of the sacrococcygeal joint.Overall, these findings indicate the complex anatomy that is underlying the current symptoms and the degree of abnormality strongly supports the likelihood of demonstrating sufficient severity of an abnormality as to expect clinically significant symptoms.On (b)(6) 2021, the patient presented for physical therapy.It was noted she had been in pt for 4 months.She was struggling mentally with her condition, and was able to stand for 10 minutes the day prior but was very fatigued today, though not as fatigued as she once was.She was 3 weeks out from her procedure.The assessment was that the patient continued to respond well to physical therapy interventions that focus on down regulation of central nervous systems with desensitization techniques, and manual therapy.On (b)(6) 2022, spinal x-rays showed l4-5 degenerative disc disease (ddd) and lower lumbar facet arthropathy.On (b)(6) 2022, the patient presented to a spine center with the chief complaints of s4 tarlov cyst and possible right pudendal nerve entrapment, l4-5 ddd, and status post multiple injections including nerve blocks at pudendal nerve, obturator, impar ganglion, and piriformis with 60% improvement within 2 hours of the nerve block with waning after 6 days.She was taking percocet 5mg as needed.As of (b)(6) 2022, the patient was able to sit and stand for longer periods of time since the injections.In addition, the patient was undergoing a gastrointestinal work up and is planning to eventually have a colonoscopy to further evaluate her rectal pain.She also notes a history of neck pain which has worsened since her pelvic symptoms worsened.She has not completed recent physical therapy.Her surgeon will get imaging to further evaluate this complaint as well.The plan was sacral mri with tarlov cyst protocol, lumbar spine mri, request injection records, follow-up for neurogenital testing, cervical spine x-rays and mri for persistent neck pain, cervical spine pt, and telemedicine appointment after sacral mri and follow-up after that.Boston scientific received an additional information on january 12, 2023, as follows: on (b)(6) 2021, the patient underwent a robotic-assisted laparoscopic removal of retropubic mesh, vaginal removal of the retropubic sling, kelly plication, cystoscopy, and a bilateral pudendal nerve block to address the complications of the implanted sling, pudendal neuralgia, and spastic pelvic floor syndrome.The procedure findings were of properly placed retropubic mesh and significant bilateral spasm of pelvic floor muscles.There were no reported patient complications.
|
| |
|
Manufacturer Narrative
|
|
Block h2: additional information blocks d4 (lot number and expiration date), d6b (explant date), and h4 (device manufacture date) has been updated based on the additional information received on august 9, 2023.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.The implanting surgeon is: (b)(6) united states, 92868 attending physician: (b)(6) united states, (b)(6) ca, united states 90095-0001 block h6: the following imdrf patient codes capture the reportable events of: e2311 - discomfort e2330 - pain e1705 - burning sensation e1405 - dyspareunia e020201 - anxiety e1715 - scar tissue e1301 - dysuria e0123 - nerve damage e020202 - depression the following imdrf impact codes capture the reportable events of: f2303 - medication required f1202 - disability f18 - rehabilitation f23 - unexpected medical intervention f1903 - device explantation.
|
| |
|
Search Alerts/Recalls
|
|
|
