BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); No Code Available (3191); Urinary Incontinence (4572)
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Event Date 03/04/2011 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2011, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(4).The complaint device 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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Note: this manufacturer report pertains to the first of two devices used during two different procedures.It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a hysteroscopy, anterior and posterior vaginal mesh repair and uterine suspension procedures performed on (b)(6) 2011 to treat recurrent prolapse.As reported by the patient's attorney, the patient suffered from stress urinary incontinence after the implantation of the uphold vaginal support system device and had a revision surgery with an advantage system device on (b)(6) 2011.Subsequently, the patient had to undergo permanent sacral stimulation performed on (b)(6) 2014.The patient was also implanted with a non-bsc device on (b)(6) 2004.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) 2011, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient code 3191 captures the reportable event of revision surgery and permanent sacral stimulation.Block h10: the complaint device 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: block g2 (report source (other)), h6 (impact codes) and h10 have been corrected.Block h6: impact code f1905 captures the reportable event of revision surgery.
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Event Description
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Note: this manufacturer report pertains to the first of two devices used during two different procedures.It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a hysteroscopy, anterior and posterior vaginal mesh repair and uterine suspension procedures performed on (b)(6) 2011 to treat recurrent prolapse.As reported by the patient's attorney, the patient suffered from stress urinary incontinence after the implantation of the uphold vaginal support system device and had a revision surgery with an advantage system device on (b)(6) 2011.Subsequently, the patient had to undergo permanent sacral stimulation performed on (b)(6) 2014.The patient was also implanted with a non-bsc device on (b)(6) 2004.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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