BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Perforation (2001); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 03/12/2018 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an uphold lite was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion), back pain, vaginal pain, pelvic pain, groin pain, perineum pain, anal pain, rectal pain, thigh pain, other pain (pain when i cough or sneeze or if i get up to fast or if i stand for many hours at work ), painful intercourse, inability to have intercourse, offensive vaginal discharge, difficulties with bowel motions, incontinence not present before implant, recurrent incontinence, aggravated incontinence, damage, and psychiatric injury.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the uphold lite implant under general anesthesia for the following purpose: having pain and not being able to hold urine and always leaking.Nonsurgical treatments: on (b)(6) 2017 the patient commenced pain medication: nurofin, panadol, tramadol, for: pain relief.
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Manufacturer Narrative
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(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Blocks a1, b5, d4: lot number, expiration date an udi, d6: implant date, e1 (below) and g1: manufacturing site have been updated based on the ai received on november 2, 2022.Block a1: meshc-20210921-9d5bee3e.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the events below: e2006 - mesh erosion and exposure.E0206 - psychiatric injury.E2330 - pain.E1405 - painful intercourse.E2401 - "damage." e2114 - buttonholing during the implant.
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Event Description
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It was reported to boston scientific corporation that an uphold lite was implanted on february 7, 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; other pain (pain when i cough or sneeze or if i get up to fast or if i stand for many hours at work ); painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the uphold lite implant under general anesthesia for the following purpose: having pain and not being able to hold urine and always leaking.Nonsurgical treatments: on february 7, 2017 the patient commenced pain medication: nurofin, panadol, tramadol, for: pain relief.Additional information received on november 2, 2022: on (b)(6) 2017, the uphold lite with capio slim device was implanted as part of a procedure to address uterovaginal prolapse that included a bilateral salpingectomy, ap tvssf (anterior/posterior transvaginal sacrospinous ligament fixation), and cystoscopy.Additionally, the procedure was performed as a result of unsuccessful menorrhagia treatment.After placement of the uphold lite device, there was buttonholing noted in the right vault.The tissue behind the mesh was opened and mobilized, and the mesh was loosened and oversewn.On (b)(6) 2018, the patient underwent vaginal mesh excision due to dyspareunia and mesh erosion.Mesh exposure was visible in the right lateral vagina and was excised.Cystoscopy showed normal results; no visible mesh was noted on cystoscopy.
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Search Alerts/Recalls
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