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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 Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Event Date 09/11/2017
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
It was reported to boston scientific corporation that an uphold was implanted on (b)(6) 2014 and a solyx was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008 the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.Device 2 of 2.
 
Manufacturer Narrative
Blocks a1, b5 and d4 lot number have been updated based on the additional information received on november 17, 2022.Block b3 date of event: date of event was approximated to september 11, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeons are (b)(6) dr.(b)(6) dr.(b)(6) campus.Block h6: imdrf patient codes e2006, e2330, e1405 and e1401 capture the reportable events of erosion, pain, dyspareunia and abnormal vaginal discharge.Imdrf impact codes f19 capture the reportable event of surgical intervention.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a solyx sling procedure with cystoscopy + posterior vaginal repair with excision of old mesh from posterior vaginal wall + excision of previous monarc mesh performed on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury surgical interventions: on (b)(6) 2017, the patient underwent further surgery regarding the pinnacle mesh implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008, the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008, the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017, the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12930744
MDR Text Key286919431
Report Number3005099803-2021-07392
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729784784
UDI-Public08714729774044
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K081275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/18/2020
Device Model NumberM0068507000
Device Catalogue Number850-700
Device Lot Number0020177312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/10/2021
Initial Date FDA Received12/04/2021
Supplement Dates Manufacturer Received11/17/2022
Supplement Dates FDA Received12/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexFemale
Patient Weight85 KG
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