MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403831

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Nerve Damage (1979); Pain (1994); Scarring (2061); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)

Event Date 12/31/2010

Event Type  Injury  

Event Description

Additional information received indicated that the monarc sling has been implanted since 2010 and has "caused nerve damage and needs to be removed." following the implantation of the sling, the patient is experiencing severe pelvic groin pain, nerve damage, vaginal scarring, shrinkage, "very painful intercourse cannot have sex with my husband now," difficulty walking, "cannot sleep due to pain," and "electric shock like pains." there are no further patient complications reported as a result of this event.

Event Description

It was reported by the patient that following a monarc sling implantation she experienced "unexplained pain" in her pelvic floor area.She underwent an additional operation, surgery details not indicated, and the device was "no where to be found." she indicated that "it is in my body somewhere but nobody knows where." no additional patient complications have been reported in relation to this event.

• Brand Name: AMS MONARC 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: 3975877
• MDR Text Key: 5702051
• Report Number: 2183959-2014-00342
• Device Sequence Number: 1
• Product Code: OTN
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2014

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: 11/16/2013
• Device Catalogue Number: 72403831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 08/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• 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): Hospitalization; Required Intervention