BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-817 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 05/05/2014 |
Event Type
Injury
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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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Event Description
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It was reported to boston scientific corporation that a uphold lite implant and a advantage implant were implanted into the patient on (b)(6) 2013.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; rec incont; damage; psych; oth pain: back of legs.Surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the advantage implant/uphold lite implant under general anesthesia for the following purpose: prepare of complications and some mesh removal in areas of protrusion and erosion.On (b)(6) 2017 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: to resolve complications and remove mesh where possible.On (b)(6) 2021 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: botox injections to pelvic floor and vagina to reduce pain.On (b)(6) 2020 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: examination and assessment of pelvic floor, bladder.Nonsurgical treatments: on (b)(6) 2008 the patient commenced pain medication: tramadol for the treatment of: pain management.On (b)(6) 2017 the patient commenced psychological medication: fluoxetine for the treatment of: major depression treatment.On (b)(6) 2013 the patient commenced other medication (please specify): lyrica for the treatment of: pain management.On (b)(6) 2008 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: difficulty with urination, pelvic floor pain.Treatment duration: 1 year.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): oestrogen for the treatment of: pain and dryness.The patient was treated with other (please specify).On (b)(6) 2017 the patient commenced psychological medication: zuban for the treatment of: major depression treatment.On (b)(6) 2013 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pain management for back and legs.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: bowel and bladder incontinence, pelvic floor pain.Treatment duration: 6 months.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: bowel and bladder incontinence, pelvic floor pain.On (b)(6) 2017 the patient commenced other (please specify) for the treatment of: to empty bladder at least 4 times daily.
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Event Description
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It was reported to boston scientific corporation that a uphold lite implant and a advantage implant were implanted into the patient on (b)(6) 2013.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; rec incont; damage; psych; oth pain: back of legs.Surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the advantage implant/uphold lite implant under general anesthesia for the following purpose: repare of complications and some mesh removal in areas of protrusion and errosion.On (b)(6) 2017 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: to resolve complications and remove mesh where possible.On (b)(6) 2021 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: botox injections to pelvic floor and vagina to reduce pain.On (b)(6) 2020 the patient underwent further surgery regarding the uphold lite implant/advantage implant under general anesthesia for the following purpose: examination and accessment of pelvic floor, blooder.Nonsurgical treatments: on (b)(6) 2008 the patient commenced pain medication: tramadol for the treatment of: pain management.On (b)(6) 2017 the patient commenced psychological medication: fluoxetine for the treatment of: major depression treatment.On (b)(6) 2013 the patient commenced other medication (please specify): lyrica for the treatment of: pain management.On (b)(6) 2008 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: difficulty with urination, pelvic floor pain.Treatment duration: 1 year.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): oestrogen for the treatment of: pain and dryness.The patient was treated with other (please specify).On (b)(6) 2017 the patient commenced psychological medication: zuban for the treatment of: major deppression treatment.On (b)(6) 2013 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pain management for back and legs.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: bowel and bloder incontinence, pelvic floor pain.Treatment duration: 6 months.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: bowel and bloder incontinence, pelvic floor pain.On (b)(6) 2017 the patient commenced other (please specify) for the treatment of: to empty blooder at least 4 times daily.
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Manufacturer Narrative
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Block a1: (b)(6).Block d4, h4: 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.Block h10: 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06527.
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