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

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

Patient Problems Abscess (1690); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Chills (2191); Dysuria (2684); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 12/30/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with pelvic pain with stress urinary incontinence and pelvic adhesions.She then underwent laparoscopy, lysis of pelvic adhesions and urethropexy with solyx device procedures on (b)(6) 2010.On (b)(6) 2010, the patient presented with pelvic pain.Reportedly after her surgery, she was not feeling well and could not take pain medication as it made her feel sick.She was having moderate amount of pubic bone pain, burning pain along her lower sides of pelvis, pain in the suprapubic suture and vaginal pressure.Additionally, she was feeling hot and cold and had light vaginal bleeding with straining.Exam showed the incisions were intact and well-healed without any signs of infection or drainage.The assessment was acute postop pain (noted as normal but not well-controlled), and the patient was prescribed naprosyn.On (b)(6) 2011, the patient presented with problems starting the urine stream but was able to empty bladder when voiding, and vaginal dryness which was uncomfortable (vagifem rx was reportedly not working).The patient was also treated for uti after her bladder repair surgery.The assessment was dysuria, a urine culture was submitted, and the patient was prescribed premarin vaginal for dryness.Urine culture showed no growth.On (b)(6) 2013, the patient presented with swollen lymph nodes in the vaginal area and yeast infection.The assessment was noted as yeast infection and vaginitis.Genital culture showed routine genital flora.On (b)(6) 2013, she presented with enlarged lymph nodes on her left groin, yeast infection and vaginitis.She had been treated with a course of antibiotics (keflex) but there were no improvements.Keflex was discontinued and the patient was rescheduled for resection of left groin mass.On (b)(6) 2013 the patient underwent resection of left inguinal mass.A 1.5 cm incision was made at the inguinal area on the left side above the mass.Right away a pus-type of material came out indicating infection.The lymph node of the inguinal area was removed and sent to pathology, and culture was taken.After cleaning the area of debris, the incision was closed.The postoperative diagnosis was recorded as left inguinal area abscess.On (b)(6) 2013, the patient presented for a follow up 1 week post resection of large groin mass.Medical records note the mass was a "left groin abscess." exam found that the surgical incision edges were approximated, there was no pain, drainage, redness or swelling.The patient was advised to return in 2 weeks.An aerobic bacterial culture showed no growth.On (b)(6) 2013, the patient presented for a 2-week follow up and reported that her cyst (also reported as left groin boil) has not healed and has grown again.Exam revealed a swollen inguinal lymph node and a yeast infection.Bacterial culture of the left groin was submitted, and the patient was prescribed bactrim and advised to discontinue cleocin hcl.The bacterial culture showed no growth.On (b)(6) 2013, the patient presented for an appointment to follow up and her medications for a possible infection.She was still not feeling well.She experienced back pain, fatigue, fever/chills, nausea and loss of appetite.Blood in urine was also reported.She had finished her fourth round of antibiotics the day prior.Her lesion was reportedly healing better.Exam findings included mild costovertebral angle (cva) tenderness and mild suprapubic tenderness.A urine culture was submitted, and the patient was referred to urgent care for a rocephin injection.The urine culture showed no growth.On (b)(6) 2013, the patient presented for her yearly exam/pap and reported a chief complaint of vaginal dryness and requested a refill of postmenopausal hormone replacement therapy (hrt).The patient was diagnosed with atrophic vaginitis and was advised to refill her hrt and was started on topical estrace cream.On (b)(6) 2014, the patient presented for her yearly exam/pap and reported a chief complaint of pelvic pain.Medical records of the physician exam note no abnormal findings.The assessment was documented as "annual gyn (pap) exam, new." no additional information regarding the nature of the pelvic pain or additional assessment of it is noted in the medical records provided.On (b)(6) 2020 the patient underwent diagnostic laparoscopy, removal of midurethral sling, and cystoscopy for dyspareunia and vaginal pain.There were no adhesions, masses, or cysts.There was some inflammation of the peritoneal surfaces suggestive of possible pelvic endometriosis.Cystoscopy revealed no evidence of mesh erosion into the bladder.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Solyx implantation was performed by: (b)(6) hospital medical center the device was removed by: (b)(6) regional hospital (b)(6) (b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem 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 driv; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12889056
• MDR Text Key: 281392876
• Report Number: 3005099803-2021-06127
• 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: Other
• Type of Report: Initial
• Report Date: 11/29/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/30/2021
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female