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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068503000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Adhesion(s) (1695); Anemia (1706); Erosion (1750); Diarrhea (1811); Fever (1858); Fistula (1862); Micturition Urgency (1871); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Ischemia (1942); Nausea (1970); Nerve Damage (1979); Pain (1994); Pneumonia (2011); Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Chills (2191); Stenosis (2263); Urinary Frequency (2275); Obstruction/Occlusion (2422); Renal Impairment (4499); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 03/30/2015 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a lynx system was implanted into the patient during a procedure performed on (b)(6) 2009 for the treatment of stress urinary incontinence.On (b)(6) 2015, the patient had an operative revision of stoma with tapering revision of fascial sling (and removal of prior obturator sling), with extensive exploration for mesh, though none found.On (b)(6) 2016, the patient presented with significant mesh complications.She had a neurogenic bladder, poor bladder contractility, urgency, urgent incontinence, recurrent urinary infections and sepsis.The sling procedure reportedly resulted in urinary retention as there was a neuropathic dysfunction, with significant scoliosis and a right hand that was not usable for any fine manipulation and she was unable to do self-catheterization.She had a urethrolysis and a sling procedure that failed to maintain continence.Because of small bladder capacity and the inability to urinate, it was decided to perform a cecum cystoplasty, with the appendix being the continent stoma.Ultrasound and ct scan showed multiple areas of prior coaptite injection that calcified and had grown in size inside the urethral wall.On the same day, the patient was diagnosed with recurrent urinary infections and sepsis, urinary incontinence, post creation of a continent augmentation using an appendix with incontinence, neurogenic bladder, with poor bladder contractility, complications of mesh surgery requiring removal for obstruction and post partial sling (failed).She underwent extensive transvaginal urethrolysis, transvaginal excision of a urethrectomy, anterior vaginal wall reconstruction, creation of a left in situ martius flap, exploratory laparotomy, revision of continent stoma (appendix), with tapering and reposition and plication of the ileocecal valve around the base of the appendix.On (b)(6) 2016, the patient was diagnosed with post transvaginal closure of the urethra, complications of mesh surgery, posterior continent pouch with tapered appendix, and stomal stenosis.She then underwent revision of stoma.Reportedly, the patient presented with stomal stenosis particularly a ring of scar in the distal segment of the stoma.On (b)(6) 2016, the patient presented with recurrent infections, pain, urinary urgency and urinary frequency for which the closure of the urethra and a continent augmentation using appendix were performed.However, she developed stomal stenosis and it was difficult for her to pass a catheter.There was a very small fibrotic ring in the area.Her diagnoses included complications of mesh surgery, post urethrectomy and creation of a continent pouch (appendix) and recurrent stomal stenosis.She then underwent excision of distal appendix for stomal stenosis and advancement and reconstruction of distal appendix using skin flap.On (b)(6) 2016, the patient reported problems with recurrent urinary tract infections and recurrent stenosis due to probable ischemia at the end of the appendix.She then underwent revision of continent stoma.On (b)(6) 2016, the patient underwent sp tube placement.On (b)(6) 2016, the patient was diagnosed with post continent augmentation, post closure of the urethra for mesh complications (obturator sling), recurrent urinary tract infection, and incompetent and obstructed stoma (appendix).She then underwent abdominal exploration and lysis of adhesions, excision of appendix stoma, creation of a double monti continent stoma using small bowel, and reimplantation of the continent stoma.During the exploration, it was tried to use the appendix as a continent stoma.However, the appendix was partially obstructed and not functional, and she required surgeries to repair the appendix that were not successful.The patient then had incontinence of the stoma for which she presented for revision.She was suffering from recurrent urinary tract infection requiring picc lines and iv antibiotics.The source of infection was not clear while the cystoscopy was normal.There were no stones or tumors and no mesh was seen.Following this surgery, the patient developed left hand neuralgia.She had a prolonged hospitalization due to recurrent fevers requiring iv antibiotics and also developed a small bowel obstruction.She was discharged on (b)(6) 2017 and was readmitted on (b)(6) 2017 with superficial abdominal abscess near site of suprapubic tube, requiring incision and drainage as well iv antibiotics.She was discharged on (b)(6) 2017 and developed ec fistula.On (b)(6) 2017, her diagnoses included enterovesical fistula which was repaired; incompetent continent stoma (post closure of bladder neck and creation of a double monti stoma); repair of augmented bladder fistula, tapering of efferent stoma; and placement of suprapubic catheter.On (b)(6) 2017, the patient underwent a cystoscopy and her diagnoses included multiple mesh complications, bladder augmentation with recurrent urinary tract infections, stoma complications and ecfs.On (b)(6) 2017, the patient presented with disabling incontinence of the stoma, leaking urine around the foley catheter, and urinary tract infection.She had a picc line requiring iv antibiotics.The bladder was colonized from bacteria that was very hard to cure.She then underwent revision of continent pouch (tapering and crossover of the anterior recti musculature).She was diagnosed with complications of mesh surgery, recurrent urinary tract infection, post creation of a continent pouch, post multiple stomal revisions and recurrent incontinence of the stoma.On (b)(6) 2017, her bacterial culture urine result was abnormal.On (b)(6) 2018, the patient was diagnosed with complications of mesh surgery, recurrent urinary infections and sepsis, extended spectrum beta-iactamase urinary infection, post closure closure of the urethra and creation of a continent stoma, using right colon, post revision of stoma (multiple times), incontinence of the stoma and severe urinary infections, resistant to antibiotics.She then underwent extensive abdominal exploration and lysis of adhesions; removal, excision of continent stoma; excision of augmentation cystoplasty and supratrigonal cystectomy; and ileal conduit with bilateral ureteric reimplantation in the ileum.On (b)(6) 2018, the patient presented for well woman exam.She had urostomy/ileal conduit secondary to mesh erosion of her bladder.She reported she completed a 14-day course of ertapenam for an e.Coli uti.She suspected she might have another infection as her stoma was irritating her again.Her physical exam showed atrohpic external female genitalia, urethral atrophy and atrophic rugae.On (b)(6) 2020, the patient's active problems included urinary retention; neurogenic dysfunction of the urinary bladder; history of esbl e.Coli infection; bladder leak; chronic abdominal pain; nausea and vomiting in adult; pyelonephritis; and lower back pain of over 3 months duration.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: september 1, 2014 to october 31, 2014.Asr exemption number: e2013036.Pro code: otn.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The surgeons are (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.
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Manufacturer Narrative
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Correction to blocks b5 and h6: patient codes 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 surgeons are (b)(6).Block h6: patient codes e1715, e2314, e1906, e1309, e1310, e0123, e2337, e2015, e2006, e172001, e2328, e2101, e2330, e0301, e0306, e2401, e0733, e0509 and e1305 capture the reportable events of scar tissue, fistula, infections, urinary retention, urinary tract infection, nerve damage, stomal stenosis, atrophy, erosion, abscess, obstruction, adhesion, pain, anemia, sepsis, neurogenic bladder, pneumonia, ischemia and acute kidney injury.Impact codes f1901, f1903 and f2303 capture the reportable events of additional surgeries, sling removal and medications.Block h10: 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.
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Event Description
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The patient has neuropathic dysfunction, with significant scoliosis and a right hand that is not usable for any fine manipulation.She has a history of cervical spinal surgeon.She was also implanted with an uphold vaginal support system on (b)(6) 2009.It was reported to boston scientific corporation that a lynx system was implanted into the patient during a procedure performed on (b)(6) 2009 for the treatment of stress urinary incontinence.After the sling implant, the patient suffered severe pain and still had leakage.She had a second surgery on or around (b)(6) 2009, and the physician tried to remove the sling.Despite the surgery patient still experienced leakage with severe pain and discomfort.On (b)(6) 2015, the patient had an operative revision of stoma with tapering revision of fascial sling (and removal of prior obturator sling), with extensive exploration for mesh, though none found.On (b)(6) 2016, the patient presented for surgery following significant mesh complications.She had a neurogenic bladder, poor bladder contractility, urgency, urgent incontinence, recurrent urinary infections and sepsis.The sling procedure reportedly resulted in urinary retention as there was a neuropathic dysfunction, with significant scoliosis and a right hand that was not usable for any fine manipulation and she was unable to do self-catheterization.She had a previous urethrolysis and a sling procedure that failed to maintain continence.Because of small bladder capacity and the inability to urinate, a cecum cystoplasty had been performed, with the appendix being the continent stoma.The patient developed recurrent urinary tract infections and sepsis.Ultrasound and ct scan showed multiple areas of prior coaptite injection that calcified and had grown in size inside the urethral wall.It was noted that the only solution to eliminate the source of infection and stones was a urethrectomy.Repair of the stoma was also planned.On (b)(6) 2016, she underwent extensive transvaginal urethrolysis, transvaginal excision of a urethrectomy, anterior vaginal wall reconstruction, creation of a left in situ martius flap, exploratory laparotomy, revision of continent stoma (appendix), with tapering and reposition and plication of the ileocecal valve around the base of the appendix.Intraoperative findings included: vaginal wall was very short, narrow, and atrophic; the retropubic space was significant for adhesions and fixation of the urethra and the bladder wall to the posterior aspect of the pubic bone, requiring this extensive urethrolysis; and a significant amount of old calcified coaptite from prior injection, without a true abscess, multiple areas periurethrally were found, including some cystic areas.On (b)(6) 2016, the patient presented for revision of stoma for stomal stenosis particularly a ring of scar in the distal segment of the stoma.An elliptical excision was made over the hypertrophic narrow skin until normal margins of the bowel were visualized.An anastomosis of the end of the appendix to the skin using 6 sutures of 3-0 vicryl was performed.The catheter was irrigated with antibiotic solution.The patient was discharged home on oral antibiotics.She was to return the following week for catheter removal and resume self-catheterization.On (b)(6) 2016, the patient fell getting out of bed and was diagnosed with an episode of pyelonephritis.She had chills and a fever.She was hypotensive in the hospital.She received fluids and antibiotics, after which she developed diarrhea.On (b)(6) 2016, the patient presented for excision of distal appendix for stomal stenosis and advancement and reconstruction of distal appendix using skin flap.The recurrent stomal stenosis had made it difficult for the patient to pass a catheter.During the procedure, the ring of stenosis was excised, the stoma was anastamosed to the skin, and was wide open and an easy transfer of a foley catheter 12 was achieved.The patient was transferred to the recovery room in good condition.There was no complication or bleeding.On (b)(6) 2016, the patient reported problems with recurrent urinary tract infections and recurrent stenosis due to probable ischemia at the end of the appendix.She then underwent revision of continent stoma.On (b)(6) 2016, the patient underwent sp tube placement.On (b)(6) 2016, the patient presented with recurrent urinary tract infections requiring picc lines and iv antibiotics, and incontinence of the stoma.Cystoscopy did not show any clear source of infection, and there were no stones or tumors and no mesh seen.She then underwent abdominal exploration and lysis of adhesions, excision of appendix stoma, creation of a double monti continent stoma using small bowel, and reimplantation of the continent stoma.During the exploration, it was found that the stoma in the right lower quadrant (appendix) was ischemic and had to be dilated in order to pass the catheter.Besides that, the stoma was incontinent.On the day of surgery the patient was transfused 2 units of prbc due to anemia with appropriate response.On (b)(6) 2016, the patient developed sepsis with coag negative staph and infectious disease was consulted.The patient was transitioned from ciprofloxacin to vancomycin, and shortly thereafter she was started on zosyn for gram-negative coverage.Both her catheters (stomal and suprapubic) were irrigated with duobiotic solution twice daily during her hospitalization.Following surgery the patient complained on left upper arm and hand weakness in the median nerve distribution.Both occupational health and neurology were consulted, with neurology recommending imaging studies.Mri cervical spine/lue brachial plexus was done and was unremarkable.Following imaging neurology recommended further outpatient workup with emg/ncs.Both zosyn and vancomycin were discontinued by the infectious disease team and meropenem was started for pneumonia.Around the same time the patient experienced an acute kidney injury (aki) to creatinine of 2.5 from baseline of 0.6.Nephrology was consulted, and vancomycin was thought to be the source of kidney injury.Creatinine was monitored closely and eventually down-trended back to normal levels.On (b)(6) 2016, the patient was noted to have likely ileus and she was made npo.On (b)(6) 2016, all antibiotics were stopped.On (b)(6) 2016, due to continued ileus an ng tube was placed and kept to wall suction.Tpn was started at this time.Ng was removed on (b)(6) 2016, and the patient was started on a regular diet and tpn was weaned.Shortly thereafter the patient again developed abdominal distension, abdominal pain and nausea with absence of bowel movements.Ct was carried out and demonstrated small bowel obstruction.The patient's ng tube was replaced.Abdominal exam improved and the patient began to pass flatus and bowel movements.The patient's ng was removed and she was started on a clear liquid and later full liquid diet.On (b)(6) 2017, the patient was afebrile, hemodynamically stable, tolerating po, passing flatus, ambulating without assistance, pain was well controlled, and incisions were clean, dry, and intact.She was discharged home in stable condition with home health services arranged for daily irrigation of both stomal and suprapubic catheters.The patient was readmitted on (b)(6) 2017 with superficial abdominal abscess near site of suprapubic tube, requiring incision and drainage as well iv antibiotics.She was discharged on (b)(6) 2017 and developed ec fistula.On (b)(6) 2017, her diagnoses included enterovesical fistula which was repaired; incompetent continent stoma (post closure of bladder neck and creation of a double monti stoma); repair of augmented bladder fistula, tapering of efferent stoma; and placement of suprapubic catheter.On (b)(6) 2017, the patient underwent a cystoscopy for further workup.Persistent leakage from the stoma was also noted, and an indwelling 14fr foley had been placed.Using a 17 french cystoscope monti continent stoma was examined.No strictures noted.White debris and mucous noted in the bladder.No stones, no erythema or concerning lesions in native bladder or augment areas.Bladder neck visualized.The cystoscope was removed and the patient tolerated the procedure without complication.The indwelling 14fr foley was exchanged today after the cystoscopy.Stoma revision was planned.On (b)(6) 2017, the patient presented with disabling incontinence of the stoma, leaking urine around the foley catheter, and urinary tract infection.She had a picc line requiring iv antibiotics.The bladder was colonized from bacteria that was very hard to cure.She then underwent revision of continent pouch (tapering and crossover of the anterior recti musculature).On (b)(6) 2017, her bacterial urine culture grew e.Coli.Culture urine result was abnormal.The notes on submission of the urine sample also stated "vaginal erosion due to surgical mesh, sequela," but the records do not indicate when this occurred.On (b)(6) 2018, the patient continued to have severe utis and lack of response to drainage of the bladder even with a constant foley catheter.She then underwent extensive abdominal exploration and lysis of adhesions; removal, excision of continent stoma; excision of augmentation cystoplasty and supratrigonal cystectomy; and ileal conduit with bilateral ureteric reimplantation in the ileum.There were no complications or bleeding.On (b)(6) 2018, the patient presented for well woman exam.Her history was documented as urostomy/ileal conduit secondary to mesh erosion of her bladder.She reported she completed a 14-day course of ertapenam for an e.Coli uti.She suspected she might have another infection as her stoma was irritating her again.She also reported discharge that started a couple of days ago, no odor, irritating.Was on diflucan 6-8 weeks ago for a uti with yeast.Her physical exam showed atrohpicatrophic external female genitalia, urethral atrophy and atrophic rugae.Vaginitis was diagnosed and cultures were submitted.Urinalysis and urine cultures were also submitted.On (b)(6) 2020, the patient was seen at a follow-up appointment.She had recently completed a course of iv ertapenem and po amoxicillin last week for e coli and enterococcus.She reported burning pain and abdominal pain recurring.She recently saw a new urologist who was planning a ct scan.Had initially seen a different physician for sling with mesh (placed for incontinence) that "went into her system." she underwent augmentation at that time, after which she developed neurogenic bladder.The patient's active problems included urinary retention; neurogenic dysfunction of the urinary bladder; history of esbl e.Coli infection; bladder leak; chronic abdominal pain; nausea and vomiting in adult; pyelonephritis; and lower back pain of over 3 months duration.This report was originally submitted via asr.- report identification number: (b)(4).- submission period: september 1, 2014 to october 31, 2014.- asr exemption number: e2013036.- pro code: otn.
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