MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720191-01

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

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Blood Loss (2597)

Event Date 10/14/2014

Event Type  Injury  

Event Description

(b)(4).It was reported that following the implantation of a miniarc precise sling the patient experienced mild postoperative anemia with an estimated blood loss of 150ml during the implantation surgery.She complained of intermittent dizziness and lower than normal blood pressure readings.Iron was prescribed on (b)(6) 2014 and her hemoglobin and hematocrit returned to preoperative values.The event was considered resolved/recovered with no sequelae as of 11/20/2014.There were no further patient complications reported as a result of this event.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4454118
• MDR Text Key: 5423991
• Report Number: 2183959-2015-00039
• Device Sequence Number: 1
• Product Code: PAH
• 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
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2014
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2012
• 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: ELEVATE ANTERIOR
• Patient Outcome(s): Required Intervention