MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720093-01

Device Problems Material Erosion (1214); Extrusion (2934)

Patient Problems Erosion (1750); Emotional Changes (1831); Erythema (1840); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)

Event Date 01/01/2012

Event Type  Injury  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced mental and physical pain, abdominal and pelvic pain, vaginal pain, dyspareunia, discomfort, trigonitis, inflammation, suffering, mental anguish, physical impairment, physical disfigurement, stress urinary incontinence, and permanent disabling injury.The plaintiff additionally experienced frequency of every 2 hours, nocturia x 4, urgency, mixed incontinence, urinary burning, vaginal erythema, and urinary tract infections every 3-4 months.On (b)(6) 2012 the plaintiff underwent surgery to have the mesh that had eroded into the vagina excised.The plaintiff had additional mesh excised in the physician's office on (b)(6) 2013.On (b)(6) 2013 a small portion of mesh was felt at the apex as well as 2 sutures emanating from the proximal anterior wall.On (b)(6) 2013 a "vuds" and cystoscopy was performed.On (b)(6) 2013 the eroded mesh and suture material were excised.No further patient complications were reported in relation to the event.

Manufacturer Narrative

(b)(4).

• Brand Name: ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, director ; 10700 bren rd., west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 3613125
• MDR Text Key: 4067377
• Report Number: 2183959-2014-10008
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2014
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MINIARC PRECISE; IMPLANTED
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 43 YR