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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068504000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Dizziness (2194); Ulcer (2274); Discomfort (2330); Injury (2348); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Hematuria (2558); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
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| Event Date 10/01/2011 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2007, the implant date, as no event date was reported.The complainant reported a lot number: 0ml7051801; however, this lot number does not match an obtryx device.Therefore, the device manufacture and expiration dates for the reported obtryx device cannot be determined.(b)(6).(b)(4).The complainant indicated that the device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a procedure performed on (b)(6) 2007.As reported by the patient's attorney, after the implantation, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2007, the implant date, as no event date was reported.Block d4, h4: the complainant reported a lot number: 0ml7051801; however, this lot number does not match an obtryx device.Therefore, the device manufacture and expiration dates for the reported obtryx device cannot be determined.Block e1: this was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: patient code 2348 captures the reportable event of unspecified injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block b3 date of event: date of event was approximated to october 1, 2011, the first onset of symptoms reported as october 2011, as no event date was reported.Block e1: this was reported by the patient's legal representation.The implant surgeon was: (b)(6).Block h6: patient code e1310 captures the reportable event of "history of previous urinary tract infection (several in past)." patient code e1302 captures the reportable events of "hematuria was grossly visible," "the urine was pink," "blood was only when she wipes," and "voids and sees blood on toilet paper." patient code e0506 captures the reportable events of "blood was seen in the patient's underwear only (toilet paper)," "spotting on toilet paper (she felt was vaginal)," "spotting has never stopped," "potting on toilet paper (not urine) and has done intermittently for two years," and "intermittently bleeding from an aml." patient code e2006 captures the reportable events of "mesh exposure in vagina," and "exposed mesh extending into the left pelvic sidewall." patient code e2101 captures the reportable event of "mild to moderate squamous metaplasla over the trigone dome." patient code e2330 captures the reportable events of "flank pain (left side)," "had intermittent flank pain," "flank pain after driving for 15-20 minutes," "left flank pain," "pain (clot colic)," and "pelvic pain." impact code f23 was utilized to capture the reportableevents of "treatment modalities have included antibiotics (cipro)," "cipro and now fluconazole)," and " prescribe estrace cream." impact code f1903 captures the reportable event of "excision of presumed transobturator tape obturator internist obturator internus on august 12, 2020." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks h6 and h10 have been corrected based on medical safety review on october 19, 2022 block h6: patient code e0506 captures the reportable events of "blood was seen in the patient's underwear only (toilet paper)," spotting on toilet paper (she felt was vaginal)," spotting has never stopped," potting on toilet paper (not urine) and has done intermittently for two years," and "intermittently bleeding from an aml." patient code e2339 captures the reportable event of "exposed mesh showed ulceration." patient code e2327 captures the reportable event of "exposed mesh showed necrosis." patient code e2330 captures the reportable events of "flank pain (left side)," "had intermittent flank pain," flank pain after driving for 15-20 minutes," "left flank pain," "pain (clot colic)," and "pelvic pain." patient code e1310 captures the reportable event of "history of previous urinary tract infection (several in past)." patient code e2006 captures the reportable events of "mesh exposure in vagina," and "exposed mesh extending into the left pelvic sidewall." patient code e1302 captures the reportable events of "hematuria was grossly visible," "the urine was pink," "blood was only when she wipes," and "voids and sees blood on toilet paper." impact code f23 was utilized to capture the reportableevents of "treatment modalities have included antibiotics (cipro)," "cipro and now fluconazole)," and " prescribe estrace cream." impact code f1903 captures the reportable event of "excision of presumed transobturator tape obturator internist obturator internus on august 12, 2020." impact code f12 has been used in the light of this patient seeking 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 an obtryx system - curved device was implanted into the patient during a procedure performed on (b)(6) 2007.As reported by the patient's attorney, after the implantation, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on september 23, 2022.The patient was seen and examined for complaints of a long history of leaking urine with activity and during sex, wearing a pad daily, interfering with activities of daily living.The patient additionally complained of menorrhagia every 30 days, experienced 5-6 days of clots and cramps unrelieved with nsaids.The patient had undergone office urodynamics and had documented stress urinary incontinence both by examination and by urodynamics.Options for treatment were extensively reviewed with the patient who desired definitive therapy.She was consented for the operating room.Pap smear, mammography and endometrial biopsy were within normal limits prior to the procedure.The patient then underwent a total vaginal hysterectomy, anterior and posterior repair, and transobturator midurethral sling (obtryx) with cystoscopy procedures on july 19, 2007 to treat menorrhagia and stress urinary incontinence.Findings include 8-10 weeks size globular uterus.1-2 cm left corpus luteal cyst.Ovaries and fallopian tubes were otherwise normal within limits.Stage 2 anterior wall vaginal prolapse with urethrocele.Loss of perineal body.Stage 1 posterior wall prolapse.Stage 1-2 uterine prolapse.The patient tolerated the procedure well.There were no patient complications noted at the conclusion of the procedure.The patient was taken to the recovery room in stable condition.During an office visit, the patient complained of hematuria.The hematuria was grossly visible and was noticed on 8/11.At the time the hematuria was identified the urine was noted to be pink and had no clots.Blood was seen in the patient's underwear only (toilet paper).At the onset of hematuria, the patient was doing nothing strenuous.This was associated with signs and symptoms of frequency (drinking water due hematuria), flank pain (left side) and fever (nighttime only since early october 2011).There was history of previous urinary tract infection (several in past), but no history of cigarette smoking.The patient did not have diabetes nor hypertension.Evaluation of hematuria has included urinalysis, ct stone study and renal ultrasound.Findings thus far include solid renal mass (probable angiomyolipoma (aml)).Treatment modalities have included antibiotics (cipro).The patient saw her gynecologist who prescribed cipro and now fluconazole.The patient also reported slight discomfort on her left flank.Pelvic exam by the physician was noted to be unremarkable.Due to the flank pain, it was recommended to check ct stone study, cystoscopy and may need contrast study.In the physician's assessment, there was a need to also rule out sling erosion.On (b)(6) 2011, the patient went to the emergency room due to spotting on toilet paper (she felt was vaginal) and the patient also felt to have anal fissure possibly contributing.A ct was performed which revealed a stable 1-2 mm r renal calculus.There were no ureteral stone nor hydro stones noted.A 1.2 cm left mid renal mass - likely angiomyolipoma (aml) was noted.A small amount of right pelvic fluid - likely physiologic was also noted.The urethra and bladder were noted to be normal.In the physician's assessment, since her blood was only when she wipes, the physician was not concerned about true hematuria, but has prescribed estrace cream.The physician also recommended for the patient to see a gi about rectal bleeding.If the patient has any question hematuria, ct urogram was suggested.On october 2, 2013, the patient stated that for past year, the spotting has never stopped but she's had intermittent flank pain and on those days, she voided and saw blood on toilet paper.Also has blood on toilet paper on some days she did not void.Stated that she often has flank pain after driving for 15-20 minutes.The pain improved with voiding.The patient has occasionally used ibuprofen, tylenol for the pain.In the physician's assessment, given her history, the patient needed ct urogram.On october 5, 2013, the patient had ct urogram which revealed a 1.6 cm left mid kidney lesion (16 hu -- possible aml)., which was unchanged.An additional less than 8mm low attenuation foci on the left kidney and rlp were noted which was too small to characterize.Otherwise, the patient had normal collecting systems bilaterally and bladder.On october 8, 2013, the patient returned with the ct urogram results above.The patient complained of still having left flank pain at times (2-3x/mo) which was sometimes associated with nausea.Still spotting on toilet paper (not urine) and has done intermittently for two years.Various shades of blood (pink, brown, red) were noted.The patient questioned whether she could have erosion.In the physician's assessment, the physician would like to think that she was intermittently bleeding from an aml which might cause pain (clot colic), but this should cause gross hematuria, not blood on the toilet paper.The patient underwent a cystoscopy procedure which revealed on physical examination, a tiny polyp at distal urethra.Cystoscopically, normal urethra was noted and there was no sling erosion.Normal bladder/orifices were also noted.On november 19, 2013, the patient went to the emergency room with abdominal pain.The patient underwent an excision/fulguration urethral polyp -- iv sedation/somnia.She was also advised to see a gi on november 27, 2013.On august 12, 2020, the patient underwent an excision of presumed transobturator tape obturator internist obturator internus, repair of paravaginal tissue defect, kelly plication, and cystourethroscopy procedures to treat mesh exposure in vagina and pelvic pain.Findings include a 2 cm area of exposed mesh extending into the left pelvic sidewall.On cystourethroscopy at the completion of the case there was no urethral injury there were no bladder injuries there was bilateral strong efflux of urine from the normal appearing ureteral orifice ease.The urethra was without injury or lesion mild to moderate squamous metaplasla over the trigone dome and base were normal in appearance and morphology.During the procedure, after informed consent was obtained, perioperative antibiotics have been given per scip protocol, scds were in place and running, patient was taken to the operating room where she was positioned, anesthesia was obtained and she was prepped and draped in the usual sterile fashion, a timeout was conducted.Foley catheter was placed as a means of draining urine and a lone star was used to retract the lateral vaginal edges.The exposed mesh was identified where it entered the left pelvic sidewall and grasped with a coker clamp hemostatic wheal of marcaine with epinephrine was raised along the paravaginal spaces bilaterally and along the anterior vaginal wall.A horizontal incision was made with a scalpel starting at the medial aspect of the exposed mesh.Using strongly scissors with care to hug the mesh with a spread technique and sharp dissection were necessary.The mesh was exposed out to the left pelvic sidewall.It was trimmed flush with the sidewall by palpation and visual inspection there was no more exposed mesh.The vaginal incision was then carried to the right side in a horizontal fashion as the mesh was walked away from the underlying tissue with the aid of sharp and blunt dissection once the right obturator internus was reached the mesh was excised flush with the obturator internus there was no more exposed mesh on the right by palpation or visual inspection.Copious antibiotic lavage was then undertaken.There was a paravaginal defect noted on the patient's left side as a result of mesh excision.This was closed in several layers using #3-0 vicryl in the deep layers followed by #2-0 vicryl in the superficial layers.#2-0 vicryl was used to close the dead space on the patient's right side with a single deep layer.A kelly plication was performed using #2-0 maxon care was taken not to straighten the bladder neck.The vagina was then closed with #2-0 vicryl in a horizontal fashion continuous running locked sutures.Excellent hemostasis was noted throughout the case.Using a 30 degree cystoscope with #17-french sheath and sterile water as a distention medium a complete survey of the urethra and bladder were undertaken.Findings were noted as above.The foley catheter was replaced and the patient was awakened in the operating room.The patient was taken to the recovery room in stable condition.Lap sponge and needle counts were correct x3.As she was waking up from anesthesia she was noted to have irregular heart rhythm consistent with mobitz type i block which was resolved before leaving the room in stable condition.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a procedure performed on (b)(6)2007.As reported by the patient's attorney, after the implantation, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on (b)(6)2022 the patient was seen and examined for complaints of a long history of leaking urine with activity and during sex, wearing a pad daily, interfering with activities of daily living.The patient additionally complained of menorrhagia every 30 days, experienced 5-6 days of clots and cramps unrelieved with nsaids.The patient had undergone office urodynamics and had documented stress urinary incontinence both by examination and by urodynamics.Options for treatment were extensively reviewed with the patient who desired definitive therapy.She was consented for the operating room.Pap smear, mammography and endometrial biopsy were within normal limits prior to the procedure.The patient then underwent a total vaginal hysterectomy, anterior and posterior repair, and transobturator midureteral sling (obtryx) with cystoscopy procedures on july 19, 2007 to treat menorrhagia and stress urinary incontinence.Findings include 8-10 weeks size globular uterus.1-2 cm left corpus luteal cyst.Ovaries and fallopian tubes were otherwise normal within limits.Stage 2 anterior wall vaginal prolapse with urethrocele.Loss of perineal body.Stage 1 posterior wall prolapse.Stage 1-2 uterine prolapse.The patient tolerated the procedure well.There were no patient complications noted at the conclusion of the procedure.The patient was taken to the recovery room in stable condition.During an office visit, the patient complained of hematuria.The hematuria was grossly visible and was noticed on 8/11.At the time the hematuria was identified the urine was noted to be pink and had no clots.Blood was seen in the patient's underwear only (toilet paper).At the onset of hematuria, the patient was doing nothing strenuous.This was associated with signs and symptoms of frequency (drinking water due hematuria), flank pain (left side) and fever (nighttime only since early october 2011).There was history of previous urinary tract infection (several in past), but no history of cigarette smoking.The patient did not have diabetes nor hypertension.Evaluation of hematuria has included urinalysis, ct stone study and renal ultrasound.Findings thus far include solid renal mass (probable angiomyolipoma (aml)).Treatment modalities have included antibiotics (cipro).The patient saw her gynecologist who prescribed cipro and now fluconazole.The patient also reported slight discomfort on her left flank.Pelvic exam by the physician was noted to be unremarkable.Due to the flank pain, it was recommended to check ct stone study, cystoscopy and may need contrast study.In the physician's assessment, there was a need to also rule out sling erosion.On (b)(6) 2011, the patient went to the emergency room due to spotting on toilet paper (she felt was vaginal) and the patient also felt to have anal fissure possibly contributing.A ct was performed which revealed a stable 1-2 mm r renal calculus.There were no ureteral stone nor hydro stones noted.A 1.2 cm left mid renal mass - likely angiomyolipoma (aml) was noted.A small amount of right pelvic fluid - likely physiologic was also noted.The urethra and bladder were noted to be normal.In the physician's assessment, since her blood was only when she wipes, the physician was not concerned about true hematuria, but has prescribed estrace cream.The physician also recommended for the patient to see a gi about rectal bleeding.If the patient has any question hematuria, ct urogram was suggested.On (b)(6) 2013, the patient stated that for past year, the spotting has never stopped but she's had intermittent flank pain and on those days, she voided and saw blood on toilet paper.Also has blood on toilet paper on some days she did not void.Stated that she often has flank pain after driving for 15-20 minutes.The pain improved with voiding.The patient has occasionally used ibuprofen, tylenol for the pain.In the physician's assessment, given her history, the patient needed ct urogram.On (b)(6) 2013, the patient had ct urogram which revealed a 1.6 cm left mid kidney lesion (16 hu -- possible aml)., which was unchanged.An additional less than 8mm low attenuation foci on the left kidney and rlp were noted which was too small to characterize.Otherwise, the patient had normal collecting systems bilaterally and bladder.On (b)(6) 2013, the patient returned with the ct urogram results above.The patient complained of still having left flank pain at times (2-3x/mo) which was sometimes associated with nausea.Still spotting on toilet paper (not urine) and has done intermittently for two years.Various shades of blood (pink, brown, red) were noted.The patient questioned whether she could have erosion.In the physician's assessment, the physician would like to think that she was intermittently bleeding from an aml which might cause pain (clot colic), but this should cause gross hematuria, not blood on the toilet paper.The patient underwent a cystoscopy procedure which revealed on physical examination, a tiny polyp at distal urethra.Cystoscopically, normal urethra was noted and there was no sling erosion.Normal bladder/orifices were also noted.On (b)(6) 2013, the patient went to the emergency room with abdominal pain.The patient underwent an excision/fulguration urethral polyp -- iv sedation/somnia.She was also advised to see a gi on november 27, 2013.On (b)(6) 2020, the patient underwent an excision of presumed transobturator tape obturator internist obturator internus, repair of paravaginal tissue defect, kelly plication, and cystourethroscopy procedures to treat mesh exposure in vagina and pelvic pain.Findings include a 2 cm area of exposed mesh extending into the left pelvic sidewall.On cystourethroscopy at the completion of the case there was no urethral injury there were no bladder injuries there was bilateral strong efflux of urine from the normal appearing ureteral orifice ease.The urethra was without injury or lesion mild to moderate squamous metaplasla over the trigone dome and base were normal in appearance and morphology.During the procedure, after informed consent was obtained, perioperative antibiotics have been given per scip protocol, scds were in place and running, patient was taken to the operating room where she was positioned, anesthesia was obtained and she was prepped and draped in the usual sterile fashion, a timeout was conducted.Foley catheter was placed as a means of draining urine and a lone star was used to retract the lateral vaginal edges.The exposed mesh was identified where it entered the left pelvic sidewall and grasped with a coker clamp hemostatic wheal of marcaine with epinephrine was raised along the paravaginal spaces bilaterally and along the anterior vaginal wall.A horizontal incision was made with a scalpel starting at the medial aspect of the exposed mesh.Using strongly scissors with care to hug the mesh with a spread technique and sharp dissection were necessary.The mesh was exposed out to the left pelvic sidewall.It was trimmed flush with the sidewall by palpation and visual inspection there was no more exposed mesh.The vaginal incision was then carried to the right side in a horizontal fashion as the mesh was walked away from the underlying tissue with the aid of sharp and blunt dissection once the right obturator internus was reached the mesh was excised flush with the obturator internus there was no more exposed mesh on the right by palpation or visual inspection.Copious antibiotic lavage was then undertaken.There was a paravaginal defect noted on the patient's left side as a result of mesh excision.This was closed in several layers using #3-0 vicryl in the deep layers followed by #2-0 vicryl in the superficial layers.#2-0 vicryl was used to close the dead space on the patient's right side with a single deep layer.A kelly plication was performed using #2-0 maxon care was taken not to straighten the bladder neck.The vagina was then closed with #2-0 vicryl in a horizontal fashion continuous running locked sutures.Excellent hemostasis was noted throughout the case.Using a 30 degree cystoscope with #17-french sheath and sterile water as a distention medium a complete survey of the urethra and bladder were undertaken.Findings were noted as above.The foley catheter was replaced and the patient was awakened in the operating room.The patient was taken to the recovery room in stable condition.Lap sponge and needle counts were correct x3.As she was waking up from anesthesia she was noted to have irregular heart rhythm consistent with mobitz type i block which was resolved before leaving the room in stable condition.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to july 19, 2007, the implant date, as no event date was reported.Block d4, h4: the complainant reported a lot number: 0ml7051801; however, this lot number does not match an obtryx device.Therefore, the device manufacture and expiration dates for the reported obtryx device cannot be determined.Block e1: this was reported by the patient's legal representation.The device was implanted at: (b)(6)hospital, mt.Holly, nj block h6: patient code 2348 captures the reportable event of unspecified injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks a2, b2, b3, b5, b7, d4, d6b, g1, h2, h4, h6 and h10 have been updated based on the additional information received on september 23, 2022.Blocks d7a, e1, e4 and g2 were corrected.Block b3 date of event: date of event was approximated to october 1, 2011, the first onset of symptoms reported as october 2011, as no event date was reported.Block e1: this was reported by the patient's legal representation.The implant surgeon was: (b)(6) md (b)(6)hospital of burlington county.Block h6: patient code e1310 captures the reportable event of "history of previous urinary tract infection (several in past)." patient code e1302 captures the reportable events of "hematuria was grossly visible," "the urine was pink," "blood was only when she wipes," and "voids and sees blood on toilet paper." patient code e0506 captures the reportable events of "blood was seen in the patient's underwear only (toilet paper)," "spotting on toilet paper (she felt was vaginal)," "spotting has never stopped," "potting on toilet paper (not urine) and has done intermittently for two years," and "intermittently bleeding from an aml." patient code e2006 captures the reportable events of "mesh exposure in vagina," and "exposed mesh extending into the left pelvic sidewall." patient code e2101 captures the reportable event of "mild to moderate squamous metaplasla over the trigone dome." patient code e2330 captures the reportable events of "flank pain (left side)," "had intermittent flank pain," "flank pain after driving for 15-20 minutes," "left flank pain," "pain (clot colic)," and "pelvic pain." impact code f23 was utilized to capture the reportableevents of "treatment modalities have included antibiotics (cipro)," "cipro and now fluconazole)," and " prescribe estrace cream." impact code f1903 captures the reportable event of "excision of presumed transobturator tape obturator internist obturator internus on august 12, 2020." impact code f12 has been used in the light of this patient seeking 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 an obtryx system - curved device was implanted into the patient during a procedure performed on july 19, 2007.As reported by the patient's attorney, after the implantation, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on september 23, 2022.The patient was seen and examined for complaints of a long history of leaking urine with activity and during sex, wearing a pad daily, interfering with activities of daily living.The patient additionally complained of menorrhagia every 30 days, experienced 5 to 6 days of clots and cramps unrelieved with nsaids.The patient had undergone office urodynamics and had documented stress urinary incontinence both by examination and by urodynamics.Options for treatment were extensively reviewed with the patient who desired definitive therapy.She was consented for the operating room.Pap smear, mammography and endometrial biopsy were within normal limits prior to the procedure.The patient then underwent a total vaginal hysterectomy, anterior and posterior repair, and transobturator midurethral sling (obtryx) with cystoscopy procedures on july 19, 2007 to treat menorrhagia and stress urinary incontinence.Findings include 8 to 10 weeks size globular uterus.1 - 2 cm left corpus luteal cyst.Ovaries and fallopian tubes were otherwise normal within limits.Stage 2 anterior wall vaginal prolapse with urethrocele.Loss of perineal body.Stage 1 posterior wall prolapse.Stage 1- 2 uterine prolapse.The patient tolerated the procedure well.There were no patient complications noted at the conclusion of the procedure.The patient was taken to the recovery room in stable condition.During an office visit, the patient complained of hematuria.The hematuria was grossly visible and was noticed on 8/11.At the time the hematuria was identified the urine was noted to be pink and had no clots.Blood was seen in the patient's underwear only, toilet paper.At the onset of hematuria, the patient was doing nothing strenuous.This was associated with signs and symptoms of frequency drinking water due hematuria, flank pain, left side and fever nighttime only since early october 2011.There was history of previous urinary tract infection several in past, but no history of cigarette smoking.The patient did not have diabetes nor hypertension.Evaluation of hematuria has included urinalysis, ct stone study and renal ultrasound.Findings thus far include solid renal mass (probable angiomyolipoma aml.Treatment modalities have included antibiotics cipro.The patient saw her gynecologist who prescribed cipro and now fluconazole.The patient also reported slight discomfort on her left flank.Pelvic exam by the physician was noted to be unremarkable.Due to the flank pain, it was recommended to check ct stone study, cystoscopy and may need contrast study.In the physician's assessment, there was a need to also rule out sling erosion.On november 18, 2011, the patient went to the emergency room due to spotting on toilet paper, she felt was vaginal and the patient also felt to have anal fissure possibly contributing.A ct was performed which revealed a stable 1 - 2 mm r renal calculus.There were no ureteral stone nor hydro stones noted.A 1.2 cm left mid renal mass - likely angiomyolipoma aml was noted.A small amount of right pelvic fluid - likely physiologic was also noted.The urethra and bladder were noted to be normal.In the physician's assessment, since her blood was only when she wipes, the physician was not concerned about true hematuria, but has prescribed estrace cream.The physician also recommended for the patient to see a gi about rectal bleeding.If the patient has any question hematuria, ct urogram was suggested.On october 2, 2013, the patient stated that for past year, the spotting has never stopped but she's had intermittent flank pain and on those days, she voided and saw blood on toilet paper.Also has blood on toilet paper on some days she did not void.Stated that she often has flank pain after driving for 15 - 20 minutes.The pain improved with voiding.The patient has occasionally used ibuprofen, tylenol for the pain.In the physician's assessment, given her history, the patient needed ct urogram.On october 5, 2013, the patient had ct urogram which revealed a 1.6 cm left mid kidney lesion 16 hu - possible aml, which was unchanged.An additional less than 8mm low attenuation foci on the left kidney and rlp were noted which was too small to characterize.Otherwise, the patient had normal collecting systems bilaterally and bladder.On (b)(6) 2013, the patient returned with the ct urogram results above.The patient complained of still having left flank pain at times 2 - 3 times per month, which was sometimes associated with nausea.Still spotting on toilet paper (not urine) and has done intermittently for two years.Various shades of blood (pink, brown, red) were noted.The patient questioned whether she could have erosion.In the physician's assessment, the physician would like to think that she was intermittently bleeding from an aml which might cause pain (clot colic), but this should cause gross hematuria, not blood on the toilet paper.The patient underwent a cystoscopy procedure which revealed on physical examination, a tiny polyp at distal urethra.Cystoscopically, normal urethra was noted and there was no sling erosion.Normal bladder/orifices were also noted.On (b)(6) 2013, the patient went to the emergency room with abdominal pain.The patient underwent an excision/fulguration urethral polyp, iv sedation or somnia.She was also advised to see a gi on (b)(6) 2013.On (b)(6) 2020, the patient underwent an excision of presumed transobturator tape obturator internist obturator internus, repair of paravaginal tissue defect, kelly plication, and cystourethroscopy procedures to treat mesh exposure in vagina and pelvic pain.Findings include a 2 cm area of exposed mesh extending into the left pelvic sidewall.On cystourethroscopy at the completion of the case there was no urethral injury there were no bladder injuries there was bilateral strong efflux of urine from the normal appearing ureteral orifice ease.The urethra was without injury or lesion mild to moderate squamous metaplasla over the trigone dome and base were normal in appearance and morphology.During the procedure, after informed consent was obtained, perioperative antibiotics have been given per scip protocol, scds were in place and running, patient was taken to the operating room where she was positioned, anesthesia was obtained and she was prepped and draped in the usual sterile fashion, a timeout was conducted.Foley catheter was placed as a means of draining urine and a lone star was used to retract the lateral vaginal edges.The exposed mesh was identified where it entered the left pelvic sidewall and grasped with a coker clamp hemostatic wheal of marcaine with epinephrine was raised along the paravaginal spaces bilaterally and along the anterior vaginal wall.A horizontal incision was made with a scalpel starting at the medial aspect of the exposed mesh.Using strongly scissors with care to hug the mesh with a spread technique and sharp dissection were necessary.The mesh was exposed out to the left pelvic sidewall.It was trimmed flush with the sidewall by palpation and visual inspection there was no more exposed mesh.The vaginal incision was then carried to the right side in a horizontal fashion as the mesh was walked away from the underlying tissue with the aid of sharp and blunt dissection once the right obturator internus was reached the mesh was excised flush with the obturator internus there was no more exposed mesh on the right by palpation or visual inspection.Copious antibiotic lavage was then undertaken.There was a paravaginal defect noted on the patient's left side as a result of mesh excision.This was closed in several layers using 3 - 0 vicryl in the deep layers followed by 2 - 0 vicryl in the superficial layers.2 - 0 vicryl was used to close the dead space on the patient's right side with a single deep layer.A kelly plication was performed using 2 - 0 maxon care was taken not to straighten the bladder neck.The vagina was then closed with 2 - 0 vicryl in a horizontal fashion continuous running locked suture.Excellent hemostasis was noted throughout the case.Using a 30 degree cystoscope with 17 - french sheath and sterile water as a distention medium a complete survey of the urethra and bladder were undertaken.Findings were noted as above.The foley catheter was replaced, and the patient was awakened in the operating room.The patient was taken to the recovery room in stable condition.Lap sponge and needle counts were correct x3.As she was waking up from anesthesia, she was noted to have irregular heart rhythm consistent with mobitz type i block which was resolved before leaving the room in stable condition.Additional information received on november 10 and 16, 2022.On (b)(6) 2020, the patient presented for an evaluation with gastroenterology.She reports she is having intermittent vaginal bleeding and anal pain characterized by a spasm and occasional diarrhea with incontinence.Per the physician, her symptoms are consistent with continued constipation and possible anal spasm or fissure.On (b)(6) 2020, the patient was seen for a virtual visit at the pain and spine clinic for lumbar facet arthropathy.She reported that she continues to have daily pelvic pain.The patient was seen by urology on (b)(6) 2021 for a renal cyst.Her history was assessed as follows: (b)(6) 2018 - renal mass.(b)(6) 2018 - ct for renal mass.(b)(6) 2018 - incontinence without awareness and with stress.(b)(6) 2019 - continuing left groin pain radiating to lower back.Recurring and worsening stress incontinence.(b)(6) 2020 - continued urinary incontinence and groin pain.Occasional bleeding and discharge.Awakens with urine on pad in the morning.Reports hot flashes possibly associated with use of estradiol patch.(b)(6) 2021 - underwent excision of exposed mesh.Developed pudendal neuralgia, reports urgency, frequency, bladder pain, and mixed stress and urge incontinence.Recent abdominal pain, ct showed stable 17mm left renal aml.She is undergoing physical therapy.On (b)(6) 2021, patient came for follow up for pelvic pain and lumbar facet arthropathy.She continued to have radiated low back pain.In history, she presented for initial consultation for chronic pelvic pain for about ten years.Patient reported that the pain started following bladder sling implantation.The pain was in her left inguinal region and radiates to the perineal region, radiates to the lower extremities with numbness and paresthesia.Patient had previous treatment of physical therapy.Review of systems showed positive for fatigue, constipation, diarrhea, dizziness, weakness, numbness, dysphoric mood and sleep disturbance.Complex pelvic pain condition of the patient and interventional procedure were discussed.The patient was advised to discuss with the prescribing physician whether any prescribed antiplatelet and/or anticoagulant medications can be safely discontinued prior to the planned procedure as indicated.
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Manufacturer Narrative
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Blocks b5 and h6 patient codes have been updated based on the additional information received on november 10, 2022.Block b3 date of event: date of event was approximated to october 1, 2011, the first onset of symptoms reported as october 2011, as no event date was reported.Block d4, h4: the complainant reported a lot number: 0ml7051801; however, this lot number does not match an obtryx device.Therefore, the device manufacture and expiration dates for the reported obtryx device cannot be determined.Block e1: this was reported by the patient's legal representation.The device was implanted at: (b)(6).Block e1: this was reported by the patient's legal representation.The implant surgeon was: (b)(6).Block h6: imdrf patient code e1310 captures the reportable event of "history of previous urinary tract infection (several in past)." imdrf patient code e1302 captures the reportable events of "hematuria was grossly visible," "the urine was pink," "blood was only when she wipes," and "voids and sees blood on toilet paper." imdrf patient code e0506 captures the reportable events of "blood was seen in the patient's underwear only (toilet paper)," "spotting on toilet paper (she felt was vaginal)," "spotting has never stopped," "potting on toilet paper (not urine) and has done intermittently for two years," and "intermittently bleeding from an aml." imdrf patient code e2006 captures the reportable events of "mesh exposure in vagina," and "exposed mesh extending into the left pelvic sidewall." imdrf patient code e2101 captures the reportable event of "mild to moderate squamous metaplasla over the trigone dome." imdrf patient code e2330 captures the reportable events of "flank pain (left side)," "had intermittent flank pain," "flank pain after driving for 15-20 minutes," "left flank pain," "pain (clot colic)," and "pelvic pain." imdrf patient code e0127 captures the reportable event of numbness.Imdrf impact code f23 was utilized to capture the reportableevents of "treatment modalities have included antibiotics (cipro)," "cipro and now fluconazole)," and " prescribe estrace cream." imdrf impact code f1903 captures the reportable event of "excision of presumed transobturator tape obturator internist obturator internus on august 12, 2020." imdrf impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
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Manufacturer Narrative
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Blocks b5, b6 and b7 have been updated based on the additional information received on january 4, 2023.Block b3 date of event: date of event was approximated to october 1, 2011, the first onset of symptoms reported as october 2011, as no event date was reported.Block e1: this was reported by the patient's legal representation.The device was implanted at: (b)(6) block e1: this was reported by the patient's legal representation.The implant surgeon was: (b)(6) md (b)(6) hospital block h6: imdrf patient code e1310 captures the reportable event of "history of previous urinary tract infection (several in past)." imdrf patient code e1302 captures the reportable events of "hematuria was grossly visible," "the urine was pink," "blood was only when she wipes," and "voids and sees blood on toilet paper." imdrf patient code e0506 captures the reportable events of "blood was seen in the patient's underwear only (toilet paper)," "spotting on toilet paper (she felt was vaginal)," "spotting has never stopped," "potting on toilet paper (not urine) and has done intermittently for two years," and "intermittently bleeding from an aml." imdrf patient code e2006 captures the reportable events of "mesh exposure in vagina," and "exposed mesh extending into the left pelvic sidewall." imdrf patient code e2101 captures the reportable event of "mild to moderate squamous metaplasla over the trigone dome." imdrf patient code e2330 captures the reportable events of "flank pain (left side)," "had intermittent flank pain," "flank pain after driving for 15-20 minutes," "left flank pain," "pain (clot colic)," and "pelvic pain." imdrf patient code e0127 captures the reportable event of numbness.Imdrf impact code f23 was utilized to capture the reportable events of "treatment modalities have included antibiotics (cipro)," "cipro and now fluconazole)," " prescribe estrace cream" and "interstim for pudendal neuralgia." imdrf impact code f1903 captures the reportable event of "excision of presumed transobturator tape obturator internist obturator internus on august 12, 2020." imdrf impact code f12 has been used in the light of this patient seeking 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 an obtryx system - curved device was implanted into the patient during a procedure performed on (b)(6) 2007.As reported by the patient's attorney, after the implantation, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.***additional information received on september 23, 2022*** the patient was seen and examined for complaints of a long history of leaking urine with activity and during sex, wearing a pad daily, interfering with activities of daily living.The patient additionally complained of menorrhagia every 30 days, experienced 5 to 6 days of clots and cramps unrelieved with nsaids.The patient had undergone office urodynamics and had documented stress urinary incontinence both by examination and by urodynamics.Options for treatment were extensively reviewed with the patient who desired definitive therapy.She was consented for the operating room.Pap smear, mammography and endometrial biopsy were within normal limits prior to the procedure.The patient then underwent a total vaginal hysterectomy, anterior and posterior repair, and transobturator midurethral sling (obtryx) with cystoscopy procedures on (b)(6) 2007 to treat menorrhagia and stress urinary incontinence.Findings include 8 to 10 weeks size globular uterus.1 - 2 cm left corpus luteal cyst.Ovaries and fallopian tubes were otherwise normal within limits.Stage 2 anterior wall vaginal prolapse with urethrocele.Loss of perineal body.Stage 1 posterior wall prolapse.Stage 1- 2 uterine prolapse.The patient tolerated the procedure well.There were no patient complications noted at the conclusion of the procedure.The patient was taken to the recovery room in stable condition.During an office visit, the patient complained of hematuria.The hematuria was grossly visible and was noticed on 8/11.At the time the hematuria was identified the urine was noted to be pink and had no clots.Blood was seen in the patient's underwear only, toilet paper.At the onset of hematuria, the patient was doing nothing strenuous.This was associated with signs and symptoms of frequency drinking water due hematuria, flank pain, left side and fever nighttime only since early october 2011.There was history of previous urinary tract infection several in past, but no history of cigarette smoking.The patient did not have diabetes nor hypertension.Evaluation of hematuria has included urinalysis, ct stone study and renal ultrasound.Findings thus far include solid renal mass (probable angiomyolipoma aml.Treatment modalities have included antibiotics cipro.The patient saw her gynecologist who prescribed cipro and now fluconazole.The patient also reported slight discomfort on her left flank.Pelvic exam by the physician was noted to be unremarkable.Due to the flank pain, it was recommended to check ct stone study, cystoscopy and may need contrast study.In the physician's assessment, there was a need to also rule out sling erosion.On (b)(6) 2011, the patient went to the emergency room due to spotting on toilet paper, she felt was vaginal and the patient also felt to have anal fissure possibly contributing.A ct was performed which revealed a stable 1 - 2 mm r renal calculus.There were no ureteral stone nor hydro stones noted.A 1.2 cm left mid renal mass - likely angiomyolipoma aml was noted.A small amount of right pelvic fluid - likely physiologic was also noted.The urethra and bladder were noted to be normal.In the physician's assessment, since her blood was only when she wipes, the physician was not concerned about true hematuria, but has prescribed estrace cream.The physician also recommended for the patient to see a gi about rectal bleeding.If the patient has any question hematuria, ct urogram was suggested.On (b)(6) 2013, the patient stated that for past year, the spotting has never stopped but she's had intermittent flank pain and on those days, she voided and saw blood on toilet paper.Also has blood on toilet paper on some days she did not void.Stated that she often has flank pain after driving for 15 - 20 minutes.The pain improved with voiding.The patient has occasionally used ibuprofen, tylenol for the pain.In the physician's assessment, given her history, the patient needed ct urogram.On (b)(6) 2013, the patient had ct urogram which revealed a 1.6 cm left mid kidney lesion 16 hu - possible aml, which was unchanged.An additional less than 8mm low attenuation foci on the left kidney and rlp were noted which was too small to characterize.Otherwise, the patient had normal collecting systems bilaterally and bladder.On (b)(6) 2013, the patient returned with the ct urogram results above.The patient complained of still having left flank pain at times 2 - 3 times per month, which was sometimes associated with nausea.Still spotting on toilet paper (not urine) and has done intermittently for two years.Various shades of blood (pink, brown, red) were noted.The patient questioned whether she could have erosion.In the physician's assessment, the physician would like to think that she was intermittently bleeding from an aml which might cause pain (clot colic), but this should cause gross hematuria, not blood on the toilet paper.The patient underwent a cystoscopy procedure which revealed on physical examination, a tiny polyp at distal urethra.Cystoscopically, normal urethra was noted and there was no sling erosion.Normal bladder/orifices were also noted.On november 19, 2013, the patient went to the emergency room with abdominal pain.The patient underwent an excision/fulguration urethral polyp, iv sedation or somnia.She was also advised to see a gi on (b)(6) 2013.On (b)(6) 2020, the patient underwent an excision of presumed transobturator tape obturator internist obturator internus, repair of paravaginal tissue defect, kelly plication, and cystourethroscopy procedures to treat mesh exposure in vagina and pelvic pain.Findings include a 2 cm area of exposed mesh extending into the left pelvic sidewall.On cystourethroscopy at the completion of the case there was no urethral injury there were no bladder injuries there was bilateral strong efflux of urine from the normal appearing ureteral orifice ease.The urethra was without injury or lesion mild to moderate squamous metaplasla over the trigone dome and base were normal in appearance and morphology.During the procedure, after informed consent was obtained, perioperative antibiotics have been given per scip protocol, scds were in place and running, patient was taken to the operating room where she was positioned, anesthesia was obtained and she was prepped and draped in the usual sterile fashion, a timeout was conducted.Foley catheter was placed as a means of draining urine and a lone star was used to retract the lateral vaginal edges.The exposed mesh was identified where it entered the left pelvic sidewall and grasped with a coker clamp hemostatic wheal of marcaine with epinephrine was raised along the paravaginal spaces bilaterally and along the anterior vaginal wall.A horizontal incision was made with a scalpel starting at the medial aspect of the exposed mesh.Using strongly scissors with care to hug the mesh with a spread technique and sharp dissection were necessary.The mesh was exposed out to the left pelvic sidewall.It was trimmed flush with the sidewall by palpation and visual inspection there was no more exposed mesh.The vaginal incision was then carried to the right side in a horizontal fashion as the mesh was walked away from the underlying tissue with the aid of sharp and blunt dissection once the right obturator internus was reached the mesh was excised flush with the obturator internus there was no more exposed mesh on the right by palpation or visual inspection.Copious antibiotic lavage was then undertaken.There was a paravaginal defect noted on the patient's left side as a result of mesh excision.This was closed in several layers using 3 - 0 vicryl in the deep layers followed by 2 - 0 vicryl in the superficial layers.2 - 0 vicryl was used to close the dead space on the patient's right side with a single deep layer.A kelly plication was performed using 2 - 0 maxon care was taken not to straighten the bladder neck.The vagina was then closed with 2 - 0 vicryl in a horizontal fashion continuous running locked suture.Excellent hemostasis was noted throughout the case.Using a 30 degree cystoscope with 17 - french sheath and sterile water as a distention medium a complete survey of the urethra and bladder were undertaken.Findings were noted as above.The foley catheter was replaced, and the patient was awakened in the operating room.The patient was taken to the recovery room in stable condition.Lap sponge and needle counts were correct x3.As she was waking up from anesthesia, she was noted to have irregular heart rhythm consistent with mobitz type i block which was resolved before leaving the room in stable condition.---additional information received on november 10 and 16, 2022--- on (b)(6) 2020, the patient presented for an evaluation with gastroenterology.She reports she is having intermittent vaginal bleeding and anal pain characterized by a spasm and occasional diarrhea with incontinence.Per the physician, her symptoms are consistent with continued constipation and possible anal spasm or fissure.On (b)(6) 2020, the patient was seen for a virtual visit at the pain and spine clinic for lumbar facet arthropathy.She reported that she continues to have daily pelvic pain.The patient was seen by urology on march 10, 2021 for a renal cyst.Her history was assessed as follows: 1/31/18 - renal mass 2/16/18 - ct for renal mass 1/31/18 - incontinence without awareness and with stress 12/18/19 - continuing left groin pain radiating to lower back.Recurring and worsening stress incontinence 1/3/20 0 - continued urinary incontinence and groin pain.Occasional bleeding and discharge.Awakens with urine on pad in the morning.Reports hot flashes possibly associated with use of estradiol patch.3/10/21 - underwent excision of exposed mesh.Developed pudendal neuralgia, reports urgency, frequency, bladder pain, and mixed stress and urge incontinence.Recent abdominal pain, ct showed stable 17mm left renal aml.She is undergoing physical therapy.On (b)(6) 2021, patient came for follow up for pelvic pain and lumbar facet arthropathy.She continued to have radiated low back pain.In history, she presented for initial consultation for chronic pelvic pain for about ten years.Patient reported that the pain started following bladder sling implantation.The pain was in her left inguinal region and radiates to the perineal region, radiates to the lower extremities with numbness and paresthesia.Patient had previous treatment of physical therapy.Review of systems showed positive for fatigue, constipation, diarrhea, dizziness, weakness, numbness, dysphoric mood and sleep disturbance.Complex pelvic pain condition of the patient and interventional procedure were discussed.The patient was advised to discuss with the prescribing physician whether any prescribed antiplatelet and/or anticoagulant medications can be safely discontinued prior to the planned procedure as indicated.---additional information received on january 4, 2023--- on (b)(6) 2022, the patient was diagnosed with pudendal neuralgia.Had interstim placed in 2021 and no change in incontinence.Second interstim was placed in march 2022 and shocking sensation was then developed on the left side of her body.Patient was told to turn off both units.However, she still had residua shocks.
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