MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Micturition Urgency (1871); Inflammation (1932); Itching Sensation (1943); Burning Sensation (2146); Depression (2361); Dysuria (2684); Insufficient Information (4580)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: 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)(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 device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.

Event Description

It was reported to that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on january 12, 2022: on (b)(6) 2020, the patient underwent bladder sling removal and pelvic floor reconstruction.On (b)(6) 2020, the patient was seen for her complaint of urinary urgency, burning sensation and vaginal itching.She was prescribed with diflucan and nystatin for the vaginal itching and metrogel for vaginitis.Urinalysis, urine culture were taken due to the dysuria (burning sensation).On (b)(6) 2020, the patient had a follow-up visit for mixed anxiety and depressive disorder, fatigue, and essential hypertension.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, explant date, as the specific event onset date was not 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 h6: patient codes e2401 captures the reportable event of unknown injury, e2326 captures the reportable event of vaginitis, e1301 for dysuria, e020202 for depression, e1705 for burning sensation and e1304 for urinary urgency.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.

• 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 Key: 11604041
• MDR Text Key: 243421433
• Report Number: 3005099803-2021-01342
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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 Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White