MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720159-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 11/14/2013

Event Type  Injury  

Event Description

It was reported that following the implantation of an elevate pc anterior, the patient experienced mild stress urinary incontinence with "loosing urine on coughing." the event is considered continuing (not resolved) as of (b)(6) 2014.No additional patient complications have been reported in relation to this event.

Event Description

Additional information received indicated that patient's stress urinary incontinence is de novo.Physiotherapy was administered on (b)(6) 2014.The event is considered "ongoing" as of (b)(6) 2014 and the patient is still undergoing physiotherapy.No additional patient complications have been reported in relation to this event.

Manufacturer Narrative

Additional information.

Event Description

Additional information received indicated that the event was considered continuing as of (b)(6) 2014.There were no further patient complications reported in relation to this event.

• Brand Name: AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3814216
• MDR Text Key: 4397975
• Report Number: 2183959-2014-00159
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2016
• Device Catalogue Number: 720159-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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): Required Intervention; Disability