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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068502110 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Ulcer (2274); Anxiety (2328); Discomfort (2330); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Dysuria (2684); Dyspareunia (4505); Localized Skin Lesion (4542); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
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| Event Date 09/27/2016 |
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Event Type
Injury
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Manufacturer Narrative
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As per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be documented.Date of event: the exact event onset date is unknown.The provided event date of on (b)(6) 2021 was chosen as a best estimate based on the date of the first consultation of the patient after mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter name and address: this event was reported by the patient's legal representation.The physician's are: dr.(b)(6).(b)(4).Patient had sought for a legal recourse for injuries related to the device.
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Event Description
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It was reported to boston scientific corporation that an advantage fir system device was implanted into the patient during a procedure performed in an unknown date.The patients underwent a telephone consultation for pelvic pain and vaginal bleeding on (b)(6), 2021.The patient is post-menopausal, claims she has vaginal lumps (an edge), is concerned about mesh repair, and experiences pain during sex.The patient is bleeding internally but cannot see or feel it, according to the report.It was indicated at that consult that the mesh operation was four years prior.The patient had pain, but when the device was checked a year ago "all looked ok".On (b)(6) 2022, the patient had an ongoing lumbar back pain with no radicular features.She was using a co-codamol and was warned about addictive tendency of this drug.The patient was referred to any qualified provider (aqp) back pain service.According to the report, the patient as tearful, in low mood and overwhelmed by emotions that she agreed to restart an antidepressant.Reportedly, the patient does occasionally have suicidal thoughts, but no plans to commit suicide.The patient complains of post-coital bleeding on (b)(6) 2022.The patient believes this is a mesh-related issue because she had previously consulted a gynecologist.She was informed that there was no pathology there, but she believes there may be an issue with the suture location.The patient also suffered from mixed depression and anxiety disorders.She reportedly found relief from her fluoxetine treatment.The patient is keen to raise the prescription to 40 mg despite the fact that her mood is still poor and are experiencing stress.On (b)(6), 2022, the patient still feels unfit for work and agree to undergo further medications.Moreover, the patient had an examination due to postcoital bleeding and no external abnormality was observed and tissue look a bit atrophic.On (b)(6), 2022, the patient would like to work but her back pain is too bad.The patient's mood had improved with fluoxetine by (b)(6), 2022, albeit occasionally being a little low.She was unable to work because of her poor physical health.She faces financial difficulties.She admitted to occasional binge eating and weight gain, which she finds difficult.The patient has agreed to a 60 mg fluoxetine dose increase.On (b)(6), 2022, the patient is feeling better, is less emotional, had some suicidal thoughts a few weeks ago, but these have now stopped, and she cites her children as her main source of protection.With pentreath, counseling, and social prescribing services, she is actively participating and feels well supported.The patient has reported having headaches ever since the dosage was raised.The patient said she had to lie down and take care of herself.The initial headache episode persisted for many days; no vomiting nor vision impairments occurred.Patient requests benzos for insomnia; physician notes prior history of dependency; counsels best avoided if at all feasible owing to dependence risk; discovers amitriptyline causes a hangover; advice trial taking two hours before bedtime.
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Manufacturer Narrative
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Blocks b5 and h6 (added e2311: discomfort and e2015: unspevfied tissue injury) has been updated based on the additional information received on november 18, 2022.Block a1: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be documented.Block b3 date of event: 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 first consultation of the patient after 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 physicians are: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain; e1405 - dyspareunia; e020201 - anxiety; e1301 - dysuria; e020202 - depression; e2015 - atrophy.The following imdrf impact codes capture the reportable events of: f2303 - medications.F12 - patient had sought for a legal recourse for injuries related to the device.
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Event Description
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It was reported to boston scientific corporation that an advantage fir system device was implanted into the patient during a procedure performed in an unknown date.The patients underwent a telephone consultation for pelvic pain and vaginal bleeding on (b)(6) 2021.The patient is post-menopausal, claims she has vaginal lumps (an edge), is concerned about mesh repair, and experiences pain during sex.The patient is bleeding internally but cannot see or feel it, according to the report.It was indicated at that consult that the mesh operation was four years prior.The patient had pain, but when the device was checked a year ago "all looked okay." on (b)(6) 2022, the patient had an ongoing lumbar back pain with no radicular features.She was using a co-codamol and was warned about addictive tendency of this drug.The patient was referred to any qualified provider (aqp) back pain service.According to the report, the patient as tearful, in low mood and overwhelmed by emotions that she agreed to restart an antidepressant.Reportedly, the patient does occasionally have suicidal thoughts, but no plans to commit suicide.The patient complains of post-coital bleeding on (b)(6) 2022.The patient believes this is a mesh-related issue because she had previously consulted a gynecologist.She was informed that there was no pathology there, but she believes there may be an issue with the suture location.The patient also suffered from mixed depression and anxiety disorders.She reportedly found relief from her fluoxetine treatment.The patient is keen to raise the prescription to 40 mg despite the fact that her mood is still poor and are experiencing stress.On (b)(6) 2022, the patient still feels unfit for work and agree to undergo further medications.Moreover, the patient had an examination due to postcoital bleeding and no external abnormality was observed and tissue look a bit atrophic.On (b)(6) 2022, the patient would like to work but her back pain is too bad.The patient's mood had improved with fluoxetine by (b)(6) 2022, albeit occasionally being a little low.She was unable to work because of her poor physical health.She faces financial difficulties.She admitted to occasional binge eating and weight gain, which she finds difficult.The patient has agreed to a 60 mg fluoxetine dose increase.On (b)(6) 2022, the patient is feeling better, is less emotional, had some suicidal thoughts a few weeks ago, but these have now stopped, and she cites her children as her main source of protection.With pentreath, counseling, and social prescribing services, she is actively participating and feels well supported.The patient has reported having headaches ever since the dosage was raised.The patient said she had to lie down and take care of herself.The initial headache episode persisted for many days; no vomiting nor vision impairments occurred.Patient requests benzos for insomnia; physician notes prior history of dependency; counsels best avoided if at all feasible owing to dependence risk; discovers amitriptyline causes a hangover; advice trial taking two hours before bedtime.Boston scientific received an additional information received on november 18, 2022, as follows: according to the doctor, the patient had post-coital bleeding and discomfort during intercourse on (b)(6) 2021.The patient had a previous mesh prolapse repair and wondered if this was related.She was seen and examined in the surgery, but very little was observed.She then experienced another bleed that was dark and filled with blood clots.During a subsequent pelvic examination, the doctors noticed some minor ulcerations on the anterior side of the cervix and wondered if this was related to herpes.However, because she had no history of herpes and had no other symptoms, it was decided to simply observe and wait.Furthermore, at their request, the physician evaluated her at the clinic to see if the lesions had cleared completely.Her abdomen was soft and not tender when the doctor inspected it.She felt some superficial tenderness when inserting the speculum, but she was comfortable after it was fully entered.The doctor was unable to examine her whole cervix, but what they did see seemed normal.There was no evidence of further bleeding.The patient was referred to another physician for a second opinion on (b)(6) 2022.Due to severe urinary symptoms, the patient had previously undergone a mid-urethral tvt repair in 2016.She has had persistent pain and bleeding following intercourse.She experiences a ripping sensation during sex as a result of the earlier repair.The patient was also subjected to a general anesthetic examination and tape division.At this point, there was no evidence of erosion.Unfortunately, she has had these problems ever since.Because of the persistent bleeding, the patient was referred to the post-coital bleeding service, which did not find any concerning issues.However, because her pain and bleeding are still there, she would appreciate a second opinion and advise.The patient also has a history of back pain, anxiety, depression, and hypertension.The patient was admitted on (b)(6) 2022, for an elective anesthetic examination, a cystourethroscopy, and exploration of the vaginal mid-urethral sling area.The procedure was uncomplicated.There was no evidence of tvt exposure or erosion found during the examination.There was a little region of atrophy in the right vaginal sulcus.There was no evidence of tvt exposure or erosion in this location, despite extensive exploration.Sutures were used to seal the investigated vaginal epithelium.The urethra and bladder were found to be normal, with no indication of tvt exposure or erosion in either the urethra or bladder.There was no tenderness elicited in the suprapubic area during the abdominal examination on (b)(6) 2022.A speculum examination and vaginal examination were also performed; there was no tvt exposure observed or felt; nonetheless, the skin along the right vaginal sulcus was highly atrophic, with mild tenderness at the site.There was no vaginal bleeding or contact bleeding seen.They talked about what they could do during an anesthesia examination and exploration for the mid-urethral sling area and the tender area with the very thin atrophic vaginal epithelium that can be explored, and a partial excision of the mid-urethral sling can be performed at that site along with a cystourethroscopy.
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Manufacturer Narrative
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Block h2: blocks b3, b5, b7, d6a, e1, h6 (patient code and impact code) has been updated.Block a1: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be documented.Block b3 date of event: the exact event onset date is unknown.The provided event date of september 27, 2016 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 physicians are: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2339 - small ulcerations.E2311 - discomfort.E2330 - pain.E1310 - suspected urinary tract infection.E1405 - dyspareunia.E1401 - abnormal vaginal discharge.E2015 - atrophy.E1301 - dysuria.The following imdrf impact codes capture the reportable events of: f2303 - medications.F12 - patient had sought for a legal recourse for injuries related to the device.F1905 - division of sling.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2016.On (b)(6) 2017, the patient underwent diagnostic cystoscopy and examination under anesthesia.On (b)(6) 2017, the patient underwent examination under anesthesia and division of the tension free tape.The patients underwent a telephone consultation for pelvic pain and vaginal bleeding on (b)(6) 2021.The patient is post-menopausal, claims she has vaginal lumps (an edge), is concerned about mesh repair, and experiences pain during sex.The patient is bleeding internally but cannot see or feel it, according to the report.She also reported pain in several placed, stinging sensation with urination, incontinence, and abnormal vaginal discharge.The patient noted that her symptoms had been present for 2 weeks.It was indicated at that consult that the mesh operation was four years prior.The patient had pain previously, but when the device was checked a year ago "all looked okay." on (b)(6) 2021, the patient had a suspected urinary tract infection.On (b)(6) 2022, the patient had an ongoing lumbar back pain with no radicular features.She was using a co-codamol and was warned about addictive tendency of this drug.The patient was referred to any qualified provider (aqp) back pain service.According to the report, the patient as tearful, in low mood and overwhelmed by emotions that she agreed to restart an antidepressant.Reportedly, the patient does occasionally have suicidal thoughts, but no plans to commit suicide.The patient complains of post-coital bleeding on (b)(6) 2022.The patient believes this is a mesh-related issue because she had previously consulted a gynecologist.She was informed that there was no pathology there, but she believes there may be an issue with the suture location.The patient also suffered from mixed depression and anxiety disorders.She reportedly found relief from her fluoxetine treatment.The patient is keen to raise the prescription to 40 mg despite the fact that her mood is still poor and are experiencing stress.On (b)(6) 2022, the patient still feels unfit for work and agree to undergo further medications.Moreover, the patient had an examination due to postcoital bleeding and no external abnormality was observed and tissue look a bit atrophic.Triple swabs were taken.On (b)(6) 2022, the patient would like to work but her back pain is too bad.Her low back pain was described as severe, occurring after movement rather than during, mostly left-sided and radiated to hip and into groin.Examination revealed tenderness over lower spine and left lower back but no hip tenderness and good range of motion.The patient was referred for spinal interface and hip x-rays.The patient's mood had improved with fluoxetine by (b)(6) 2022, albeit occasionally being a little low.She was unable to work because of her poor physical health.She faces financial difficulties.She admitted to occasional binge eating and weight gain, which she finds difficult.The patient has agreed to a 60 mg fluoxetine dose increase.On (b)(6) 2022, the patient is feeling better, is less emotional, had some suicidal thoughts a few weeks ago, but these have now stopped, and she cites her children as her main source of protection.With pentreath, counseling, and social prescribing services, she is actively participating and feels well supported.The patient has reported having headaches ever since the dosage was raised.The patient said she had to lie down and take care of herself.The initial headache episode persisted for many days; no vomiting nor vision impairments occurred.Patient requests benzos for insomnia; physician notes prior history of dependency; counsels best avoided if at all feasible owing to dependence risk; discovers amitriptyline causes a hangover; advice trial taking two hours before bedtime.Boston scientific received an additional information received on november 18, 2022, as follows: on (b)(6) 2021, a letter for referral requested the patient to have review in the colposcopy clinic for post-coital bleeding over the last 2 weeks.She noticed some discomfort during sex and had a small bleed afterwards.She then went on to a further bleed which was quite dark with clotted blood.She attended a&e after being advised by 111 and underwent a further pelvic examination and swabs by one of the doctors in ed.They felt they could see some small ulcerations on the anterior aspect of the cervix and wondered if this could be related to herpes.However, she does not have a history of this and did not have any other symptoms regarding it and so it was decided just to watch and wait.She was examined again in clinic to see if these lesions had cleared up.She had not had any further post-coital bleeding at that examination.She does get some fresh per-rectum bleeding but feels that at least one of her bleeds was different to this.She gets mild superficial dyspareunia during intercourse.She is not getting any abdominal pain.She has not had any vaginal discharge.She has not had any urinary or bowel symptoms.On examination, her abdomen was soft and non-tender, there was some superficial tenderness on inserting the speculum but once it was fully inserted, she was comfortable.The physician was unable to visualize her whole cervix but what he did see appeared normal and there was no evidence of any further bleeding.Swabs done by ed all came back as negative.On (b)(6) 2021, the patient was noted to have hemorrhoids and a rectal polyp.The patient was referred to another physician for a second opinion on (b)(6) 2022.Due to severe urinary symptoms, the patient had previously undergone a mid-urethral tvt repair in 2016.She has had persistent pain and bleeding following intercourse.She experiences a ripping sensation during sex as a result of the earlier repair.The patient was also subjected to a general anesthetic examination and tape division.At this point, there was no evidence of erosion.Unfortunately, she has had these problems ever since.Because of the persistent bleeding, the patient was referred to the post-coital bleeding service, which did not find any concerning issues.However, because her pain and bleeding are still there, she would appreciate a second opinion and advise.The patient also has a history of back pain, anxiety, depression, and hypertension.The patient was admitted on (b)(6) 2022, for an elective anesthetic examination, a cystourethroscopy, and exploration of the vaginal mid-urethral sling area.The procedure was uncomplicated.There was no evidence of tvt exposure or erosion found during the examination.There was a little region of atrophy in the right vaginal sulcus.There was no evidence of tvt exposure or erosion in this location, despite extensive exploration.Sutures were used to seal the investigated vaginal epithelium.The urethra and bladder were found to be normal, with no indication of tvt exposure or erosion in either the urethra or bladder.There was no tenderness elicited in the suprapubic area during the abdominal examination on (b)(6) 2022.A speculum examination and vaginal examination were also performed; there was no tvt exposure observed or felt; nonetheless, the skin along the right vaginal sulcus was highly atrophic, with mild tenderness at the site.There was no vaginal bleeding or contact bleeding seen.They talked about what they could do during an anesthesia examination and exploration for the mid-urethral sling area and the tender area with the very thin atrophic vaginal epithelium that can be explored, and a partial excision of the mid-urethral sling can be performed at that site along with a cystourethroscopy.
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