BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number 850-700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Depression (2361); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 06/15/2010 |
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 solyx was implanted on (b)(6) 2010.A second solyx implant procedure was performed on (b)(6) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; other pain: bearing down pain; painful intercourse; inability to have intercourse; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2009 the patient commenced psychological medication: pristiq sr 50 mg, anti-depressant to deal with unresolvable issues as a result of mesh/tape injuries and trauma.Treatment duration: 6.5 years.On (b)(6) 2010 the patient commenced other medication (please specify): hiprex, to inhibit bacterial growth in bladder.Treatment duration: 12 months.Device 2 of 2.
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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 # 3005099803-2021-00037.
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Event Description
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It was reported to boston scientific corporation that a solyx was implanted on (b)(6) 2010.A second solyx implant procedure was performed on (b)(6) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; other pain: bearing down pain; painful intercourse; inability to have intercourse; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2009 the patient commenced psychological medication: pristiq sr 50 mg, anti-depressant to deal with unresolvable issues as a result of mesh/tape injuries and trauma.Treatment duration: 6.5 years.On (b)(6) 2010 the patient commenced other medication (please specify): hiprex, to inhibit bacterial growth in bladder.Treatment duration: 12 months.Device 2 of 2.
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