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

Catalog Number 720127-01

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

Patient Problems Swelling (2091); Constipation (3274)

Event Date 03/10/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of an elevate posterior graft the patient presented with moderate worsening constipation.The patient had "issues pre-op with constipation and occasional impactions however, would remove stool manually." since her graft implantation, she is aware not to perform manual stool removal and medication was administered on (b)(6) 2015.The event is considered recovering/resolving (ae improving) as of (b)(6) 2015.There were no further patient complications reported as a result of this event.

Event Description

Additional information received indicated that suppositories were added to the patient's "constipation regime." the patient reported bowel movements are "not regular," and continued perineal splinting.The physician "increased doses of medication" and the event is considered not recovered/not resolved (continuing).There were no further patient complications reported as a result of this event.

Event Description

Additional information received on (b)(6) 2015 indicated that the patient "continues to eat a balanced high fiber diet" and "monitors water intake." the patient reported that "swelling in area operated on sill persists for 4-6 months s/p surgery." fiber supplementation and laxative use continued medication regime.The event is considered not recovered/not resolved (continuing).There were no further patient complications reported as a result of this event.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated that the patient stated she had "improved re constipation since surgery." "conservative management" was advised and the event was considered recovering/resolving (adverse event is improving).There were no further patient complications reported as a result of this event.

• Brand Name: AMS ELEVATE POSTERIOR 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 (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4616560
• MDR Text Key: 5594546
• Report Number: 2183959-2015-00107
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2015

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: Lay User/Patient
• Device Expiration Date: 06/25/2017
• Device Catalogue Number: 720127-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2015; 05/28/2015; 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• 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