MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502120

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Micturition Urgency (1871); Failure of Implant (1924); Incontinence (1928); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275)

Event Date 08/16/2022

Event Type  Injury  

Event Description

I had a boston scientific system sling ureteral advantage fit model #m0068502120 surgically implanted.Subsequently, i had urinary frequency, urgency, burning, incontinence and retention that required a second surgery to revise the prosthetic vaginal graft by splitting it to release tension.The urinary symptoms resolved immediately.I have only had this implant inside of me for 9 weeks.Whether i will have other long lasting symptoms is too early to tell.Some soreness that i have in my lower abdomen and right groin and upper thigh may well go away with time.If i continue to experience the symptoms, i will file another report.Fda safety report id #(b)(4).

• Brand Name: ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15690661
• MDR Text Key: 302720047
• Report Number: MW5112938
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: M0068502120
• Device Lot Number: 29660138
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ELIQUIS, REPATHA, VASCEPA.; VITAMIN D3, MELATONIN, PRILOSEC.
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White