MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403830

Device Problem Extrusion (2934)

Patient Problems Arthritis (1723); Erosion (1750); Cardiopulmonary Arrest (1765); Congestive Heart Failure (1783); Death (1802); Emotional Changes (1831); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Myocardial Infarction (1969); Internal Organ Perforation (1987); Pain (1994); Scleroderma (2062); Urinary Frequency (2275); Prolapse (2475); Organ Dehiscence (2502); Blood Loss (2597)

Event Date 02/12/2010

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced erosion, chronic inflammatory process, dyspareunia, extrusion, urgency, urinary incontinence, frequency, vaginal skin tag, trigonitis, extrusion, pelvic pain, cystocele, vaginal intraepithelial neoplasia, hypermobile urethra, mild dysplasia, bacterial vaginitis, vulvar lesion, dehiscence, condyloma acuminata, and nocturia.It was also reported that the plaintiff allegedly experienced bowel movements, organ perforation, bleeding, emotional distress and a product problem.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 2183959-2014-55533.

Manufacturer Narrative

(b)(4).Lawyer-filed report.

Event Description

Additional information received indicated that the causes of death reported were cardiopulmonary arrest, myocardial infarction, coronary artery disease, hypertension due to scleroderma, arthritis, pulmonary hypertension, and congestive heart failure.

• Brand Name: AMS MONARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 4951443
• MDR Text Key: 6634963
• Report Number: 2183959-2014-55527
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2013

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2010
• Device Catalogue Number: 72403830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2013
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 100