MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE; MESH, SURGICAL, POLYMERIC

Catalog Number 720002-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Granuloma (1876); Incontinence (1928); Pain (1994); Scarring (2061); Prolapse (2475); Blood Loss (2597)

Event Date 12/03/2010

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6), 2014 under (b)(4).Additionally, this was reported on the summary report dated (b)(6), 2014 under (b)(4).Additionally, this was reported on the summary report dated (b)(6), 2015 under (b)(4).Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, urinary problems, vaginal scarring, emotional distress and product problem.It was also reported that the plaintiff experienced cystocele, urge and stress urinary incontinence, bleeding, and vaginal spotting.The plaintiff underwent excision of suture granuloma from vagina.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #'s: 2183959-2014-38171, 2183959-2014-38197, and 2183959-2014-36760.

• Brand Name: AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
• 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: 5007194
• MDR Text Key: 23121028
• Report Number: 2183959-2014-37871
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 04/12/2013

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: 11/30/2008
• Device Catalogue Number: 720002-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2007
• 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
• Treatment: MINIARC SLING
• Patient Outcome(s): Death
• Patient Age: 65 YR