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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA Back to Search Results
Model Number M0068507000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Urinary Retention (2119); No Code Available (3191); Constipation (3274); Dyspareunia (4505)
Event Date 08/15/2016
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during a posterior vaginal wall repair and mid urethral sling procedures performed on (b)(6) 2016 to treat bladder prolapse and stress urinary incontinence.As reported by the patient's attorney, after the implantation, the patient suffered from vaginal scarring and dyspareunia.Subsequently, the patient underwent eua and excision of posterior vaginal wall scar; division of right lateral wall; fenton repair; and upper vaginal manual dilation on (b)(6) 2018.The patient was also implanted with non-bsc device on (b)(6) 2014 and had a revision surgery on (b)(6) 2014.Boston scientific has been unable to obtain additional information regarding the event to date.
 
Manufacturer Narrative
Correction: blocks b5 and h6: patient code have been updated based on the correction noticed.Block b3 date of event: date of event was approximated to august 15, 2016, implant date, as no event date was reported.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 implant surgeon is: dr.(b)(6).Block h6: patient codes e1309, e1405, e1715 and e1007capture the reportable events of acute urinary retention, dyspareunia, scar tissue and constipation.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during a posterior vaginal wall repair and mid urethral sling procedures performed on (b)(6) 2016 to treat bladder prolapse and stress urinary incontinence.After the implantation, the patient suffered from vaginal scarring and dyspareunia.Subsequently, the patient underwent eua and excision of posterior vaginal wall scar; division of right lateral wall; fenton repair; and upper vaginal manual dilation on (b)(6) 2018.The patient was also implanted with non-bsc device on (b)(6) 2014 and had a revision surgery on (b)(6) 2014.Boston scientific has been unable to obtain additional information regarding the event to date.Correction noticed on january 21, 2021.The patient experienced severe constipation and severe pain at the introitus.On (b)(6) 2016, an exam under anesthesia (eua) was performed and found that the sling was not too tight and there was no hematoma or edema on the posterior vaginal wall nor at the introitus.The sling was divided and removed, the stitches were removed at introitus, and the vagina was sutured again with loose tensioning in an attempt to reduce the pain.Following the sling removal, the patient was unable to urinate on her own.The physician noted this was most likely temporary aur (acute urinary retention) from perineal surgery and pain (reflex aur) and was taught to self-catheterize and was discharged.
 
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Brand Name
SOLYX SIS SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11167591
MDR Text Key226742901
Report Number3005099803-2021-00028
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729774044
UDI-Public08714729774044
Combination Product (y/n)N
PMA/PMN Number
K081275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM0068507000
Device Catalogue Number850-700
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age41 YR
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