MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-14 for SOLYX SIS SYSTEM M0068507000 850-700 manufactured by Boston Scientific Corporation.
[175058684]
Date of event: date of event was approximated to (b)(6) 2011 (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. Patient's additional lawyers: (b)(6). The device was implanted at (b)(6), by 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.
Patient Sequence No: 1, Text Type: N, H10
[175058685]
It was reported to boston scientific corporation that a solyx sis system was implanted during a procedure performed on (b)(6) 2011 to treat stress urinary incontinence, uterine prolapse, cystocele, and rectocele. As per reported by the patient's attorney, the patient has a negative response to the implanted device that promotes inflammation of the pelvic tissue and contributes to the formation of severe adverse reactions to the mesh. After the procedure, the patient experienced pain, development of bladder stones, and mesh erosion; consequently requiring several mesh removal and reparative surgeries. The patient has to undergo operations to locate and remove mesh, and operations to attempt to repair pelvic organs, tissue, and nerve damage. Additionally, she has to use pain control and other medications, and injections into various areas of the pelvis, spine, and the vagina. The patient also has to undergo operations to remove portions of the female genitalia. These surgical treatments and attendant medical care were performed at a different healthcare facility on (b)(4) 2018. Reportedly, as a result of the device implantation, the patient has experienced significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06420 |
| MDR Report Key | 9586903 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2011-04-12 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLYX SIS SYSTEM |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA |
| Product Code | PAH |
| Date Received | 2020-01-14 |
| Model Number | M0068507000 |
| Catalog Number | 850-700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |