MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS SPARC URETHRAL SUPPORT SLING

Device Problems Material Erosion (1214); Torn Material (3024)

Patient Problems Calcium Deposits/Calcification (1758); Incontinence (1928); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 01/01/2003

Event Type  Injury  

Event Description

In (b)(6) 2003, i had the sparc urethral support sling implanted due to the advice of my doctor.I was not made aware of any potential complications.The sling slipped, tore, embedded itself into my urethra and calcified, causing multiple and frequent urinary tract infections.The sling had eroded from the right side of the urethra and caused moderate obstruction of the mid-urethra.I underwent a cystoscopy and vaginal removal of mesh through incision.My urethra had to be reconstructed.Now i have the worst incontinence ever as i believe the sphincter muscle no longer works.

• Brand Name: SPARC URETHRAL SUPPORT SLING
• Type of Device: SPARC URETHRAL SUPPORT SLING
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS
• MDR Report Key: 4148479
• MDR Text Key: 19972450
• Report Number: MW5038462
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Patient Sequence Number: 1
• Treatment: MULTI-VITAMIN; TROSPIUM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 68